A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years (PERIWINKLE)

January 15, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES

Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
295

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Cliniques universitaires de Bruxelles Hopital Erasme
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340
        • Centre Hospitalier Neurologique William Lennox
    • Brussels-capital
      • Brussels, Brussels-capital, Belgium, 1020
        • Huderf
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • UMBAL Sveti Georgi, Klinika po pediatria i genetichni zabolyavania
  • Czechia
      • Brno - Cerna Pole, Czechia, 613 00
        • Fakultní Nemocnice Brno - Dětská Nemocnice
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole
  • France
      • Bordeaux, France, 33076
        • Chu Bordeaux - Hôpital Des Enfants
      • Bron, France, 69677
        • Hôpital Mère Enfant
      • Garches, France, 92380
        • Hopital Raymond Poincare
      • Strasbourg, France, 67098
        • Hopitaux Universitaires de Strasbourg - Hopital Hautepierre
  • Greece
      • Athens, Greece, 15236
        • General Children's Hospital Penteli
      • Athens, Greece, 11527
        • General Childrens Hospital of Athens P & A Kyriakou
  • Hungary
      • Balassagyarmat, Hungary, H-2660
        • Dr. Kenessey Albert Korhaz es Rendelointezet
      • Budapest, Hungary, H-1089
        • Heim Pal Gyermekkorhaz, Neurologiai Osztaly
      • Budapest, Hungary, H-1146
        • Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaz, Gyermekneurologia
      • Budapest, Hungary, H-1083
        • Semmelweis Egyetem, I. Sz. Gyermekgyogyaszati Klinika
      • Budapest, Hungary, H-1023
        • Szent Janos Korhaz es Eszak Budai Egyesitett Korhazak
      • Pécs, Hungary, 7623
        • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Israel
      • Haifa, Israel, 3104802
        • Bnai Zion Medical Center
  • Italy
      • Ancona, Italy, 60123
        • A.O.U. Ospedali Riuniti di Ancona Presidio Ospedaliero G. Salesi
      • Firenze, Italy, 50139
        • Azienda Ospedaliero-Universitaria Meyer
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico Nazionale Casimiro Mondino, IRCCS - Servizio di Farmacia
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center/ Department of Pediatrics, Pediatric Neurology
      • Seoul, Korea, Republic of, 120 752
        • Severance Hospital, Yonsei University Health System
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
    • Perak
      • Ipoh, Perak, Malaysia, 30990
        • Paediatric Department
  • Philippines
      • Cebu City, Philippines, 6000
        • Cebu Doctors' University Hospital
      • Manila, Philippines, 1008
        • University of Santo Tomas Hospital
      • Quezon City, Philippines, 1102
        • St. Luke's Medical Center
      • Quezon City, Philippines, 1105
        • Philippine Children's Medical Center
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Cebu Doctors' University Hospital
    • Manila
      • Sta. Cruz, Manila, Philippines, 1003
        • Center for Neurodiagnostic and Therapeutic Services
    • National Capital Region
      • Quezon City, National Capital Region, Philippines, 1100
        • Capitol Medical Center Inc.
  • Poland
      • Gdansk, Poland, 80-952
        • Klinika Neurologii Rozwojowej
      • Kielce, Poland, 25316
        • NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
      • Krakow, Poland, 31-503
        • Wojewódzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie
      • Poznan, Poland, 60-355
        • Katedra i Klinika Neurologii Wieku Rozwojowego
      • Wroclaw, Poland, 54-049
        • Oddzial Neurologii Dzieciecej, Dolnoslaski Szpital Specjalistyczny im.T. Marciniaka
  • Romania
      • Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihiatrie "Prof. Dr. Al. Obregia"
      • Bucuresti, Romania, 022102
        • Spitalul clinic de copii Dr. Victor Gomoiu
      • Iasi, Romania, 700309
        • Spitalul Clinic de Urgente pentru Copii "Sf. Maria",
      • Sibiu, Romania, 550 082
        • Spitalul de Psihiatrie Dr. Ghe. Preda
      • Timisoara, Romania, 300314
        • Centrul Medical Dr. Bacos Cosma
  • Serbia
      • Belgrade, Serbia, 11000
        • Mother and Child Healthcare Institute Dr Vukan Cupic
      • Belgrade, Serbia, 11000
        • University Children's Hospital Belgrade
      • Kragujevac, Serbia, 34000
        • Clinical Center of Kragujevac
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Institute for Child and Youth Healthcare of Vojvodina
  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's and Children's Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
  • Turkey
    • Bornova
      • Izmir, Bornova, Turkey, 35100
        • Ege University Medical Faculty Department of Pediatrics Health and Diseases
    • Farabi
      • Trabzon, Farabi, Turkey, 61080
        • Karadeniz Technical University Faculty of Medicine Farabi Hospital
    • Konak
      • Izmir, Konak, Turkey, 35210
        • Behcet Uz Children Disease and surgery Training and research hospital
      • Izmir, Konak, Turkey, 35120
        • Izmir Tepecik Training and Research Hospital
    • Pendik
      • Istanbul, Pendik, Turkey, 34890
        • Marmara University Pendik Training and Research Hospital
    • Sihhiye/ankara
      • Ankara, Sihhiye/ankara, Turkey, 06100
        • Hacettepe University Medical Faculty
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49100
        • Komunalnyi zaklad "Dnipropetrovska oblasna dytiacha klinichna likarnia"
      • Dnipropetrovsk, Ukraine, 49027
        • Komunalnyi zaklad "Dnipropetrovska dytiacha miska klinichna likarnia
      • Kharkiv, Ukraine, 61068
        • Derzhavna ustanova "Instytut nevrolohii, psykhiatrii ta narkolohii
      • Kharkiv, Ukraine, 61068
        • Derzhavna Ustanova Instytut Nevrolohii, Psykhiatrii ta Narkolohii NAMN Ukrainy,
      • Kyiv, Ukraine, 04209
        • Derzhavnyi zaklad "Ukrainskyi medychnyi tsentr reabilitatsii ditei z
      • Odesa, Ukraine, 65006
        • Komunalna ustanova "Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia",
      • Odesa, Ukraine, 65031
        • Komunalna ustanova "Odeska oblasna dytiacha klinichna likarnia", Oblasnyi tsentr rannoi
      • S. Oleksandrivka, Ukraine, 67513
        • Komunalna ustanova "Odeska oblasna psykhiatrychna likarnia 2",
      • Uzhgorod, Ukraine, 88018
        • Oblasnyi klinichnyi tsentr neirokhirurhii ta nevrolohii, viddilennia neirokhirurhii 2,
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90027
        • Children´s Hospital Los Angeles
    • Florida
      • Loxahatchee Groves, Florida, United States, 33470
        • Axcess Medical Research
      • North Palm Beach, Florida, United States, 33408
        • Laszlo J. Mate, M.D., P.A.
      • Orlando, Florida, United States, 32819
        • Pediatric Neurology, P.A.
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Neurological Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Center for Clinical and Translational Science
      • Lexington, Kentucky, United States, 40536
        • Kentucky Neuroscience Institute
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Hospital Epilepsy Monitoring Unit
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Hospital Pharmacy, UK Chandler Hosptial
      • Louisville, Kentucky, United States, 40202
        • Kosair Children's Hospital
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Physicians
      • Louisville, Kentucky, United States, 40202
        • Kosair Charities Pediatric Clinical
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Saint Peter's University Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Children's Hospital and Health Center
      • Durham, North Carolina, United States, 27710
        • Duke Clinical Research Unit
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
    • Texas
      • San Antonio, Texas, United States, 78258
        • Road Runner Research, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects and/or parent(s)/legally acceptable representative must be considered willing and able to sign consent, and complete daily seizure diaries and monitor seizure frequency.
  • Male and female epilepsy subjects, 4 to 16 years of age inclusive on the date of the Screening Visit.
  • Diagnosis of epilepsy with partial onset seizures classified as simple partial, complex partial or partial becoming secondarily generalized, according to the International League Against Epilepsy (ILAE) Diagnosis criteria.
  • Must have a partial onset seizure frequency of at least 3 seizures per 28 day period prior to screening. Must have a partial onset seizure frequency of at least 6 seizures and no continuous 4 week seizure free period during the 8 week baseline phase prior to randomization.
  • Currently receiving a stable dose of 1 to 3 antiepileptic drugs (stable within 28 days prior to screening).

Exclusion Criteria:

  • Primary generalized seizures (including in the setting of co-existing partial onset seizures) which include, for example: Clonic, tonic and clonic-tonic seizures (note that partial onset seizures that become secondarily generalized are not exclusionary); Absence seizures; Infantile spasms; Myoclonic, myoclonic atonic, myoclonic tonic seizures.
  • Lennox Gastaut syndrome, Benign Epilepsy with Centrotemporal Spikes (BECTS) and Dravet syndrome.
  • A current diagnosis of febrile seizures, or seizures related to an ongoing acute medical illness. Any febrile seizures within 1 year of screening.
  • Status epilepticus within 1 year prior to screening.
  • Seizures related to drugs, alcohol, or acute medical illness.
  • Any change in AED regimen (type of medication or dose) within 28 days of the Screening Visit or during the Baseline Phase.
  • Progressive structural CNS lesion or a progressive encephalopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Experimental: Pregabalin Level 1 (max 150 mg/day)
Drug: Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Experimental: Pregabalin Level 2 (max 600 mg day)
Drug: Pregabalin add-on therapy
Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase
Time Frame: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {-} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase
Time Frame: Day 1 up to Week 12
All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
Day 1 up to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase
Time Frame: Day 1 up to Week 12
Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28.
Day 1 up to Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events.
Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.
Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Number of Adverse Events by Severity
Time Frame: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.
Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline
Time Frame: Baseline (4 week prior to Day 1 of treatment)
The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported.
Baseline (4 week prior to Day 1 of treatment)
Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period
Time Frame: Day 1 up to Week 13
C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of "Yes" on "actual attempt") (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) ("Yes" on "preparatory acts or behavior")(C-CASA code 3); suicidal ideation ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of "yes") to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported
Day 1 up to Week 13
Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age
Time Frame: Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study.
Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age
Time Frame: Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study
Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age
Time Frame: Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study
Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task
Time Frame: Baseline (pre-dose at Day 1), Week 12
CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.
Baseline (pre-dose at Day 1), Week 12
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks
Time Frame: Baseline (pre-dose at Day 1), Week 12
CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press "Yes" response key, otherwise "no". There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.
Baseline (pre-dose at Day 1), Week 12
Number of Participants With Clinically Significant Laboratory Abnormalities
Time Frame: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN).
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Number of Participants With Vital Signs Abnormalities
Time Frame: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations
Time Frame: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion.
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time Frame: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure.
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13
Time Frame: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator.
Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 27, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A0081041
  • 2010-020852-79 (EudraCT Number)
  • XALCORY 1014 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy, Partial Seizures

Clinical Trials on Pregabalin add-on therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings