Once-A-Day Pregabalin For Partial Seizures

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures

Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design.

Study Overview

• Status: Completed
• Conditions: Epilepsies, Partial; Partial Seizures
• Intervention / Treatment: Drug: pregabalin; Drug: pregabalin; Drug: pregabalin; Drug: pregabalin; Drug: pregabalin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos Aires, Argentina, C1117ABE
    • Fundacion Argentina Contra las Enfermedades Neurologicas (FACENE)
• Bosnia and Herzegovina
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinic of Neurology,Clinical Centar University Sarajevo
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • MBAL Puls AD, Nevrologichno otdelenie
  • Pleven, Bulgaria, 5800
    • UMBAL Dr. Georgi Stranski, Vtora nevrologichna klinika
  • Sevlievo, Bulgaria, 5400
    • DKTs Akta Medika, Konsultativen kabinet po Nevrologiya
  • Sofia, Bulgaria, 1113
    • MBALNP Sveti Naum EAD, Klinika po nervni bolesti za paroksizmalnite sastoyaniya,
  • Sofia, Bulgaria, 1202
    • Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Nevrologichno Otdelenie
• Czechia
  • Litomysl, Czechia, 570 14
    • Litomyslská nemocnice, a.s.
  • Praha 4, Czechia, 140 59
    • Fakultni Thomayerova nemocnice s poliklinikou,Neurologicka klinika IPVZ/FTNsP
  • Praha 6, Czechia, 160 00
    • Neurologicka ambulance
• Germany
  • Bielefeld, Germany, 33617
    • Epilepsie-Zentrum Bethel
  • Bielefeld, Germany, 33647
    • Praxis fuer Neurologie und Psychiatrie, Psychotherapie
  • Bonn, Germany, 53105
    • Klinik fuer Epileptologie, Universitaet Bonn
  • Duesseldorf, Germany, 40212
    • Neuro Consil GmbH
  • Kehl-Kork, Germany, 77694
    • Epilepsieklinik fuer Erwachsene Epilepsiezentrum Kork
  • Muenchen, Germany, 80638
    • Studienzentrum Dr. Stephan Arnold
• Hong Kong
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital
  • Kowloon, Hong Kong
    • Department of Medicine, Queen Elizabeth Hospital
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Dr. Kennessey Albert Korhaz-Rendelointezet, Neurologiai Osztaly
  • Budapest, Hungary, 1036
    • Synexus Magyarorszag Kft.
  • Budapest, Hungary, 1145
    • Fovarosi Onkormanyzat Uzsoki utcai Korhaza, Ideggyogyaszati Osztaly
  • Dunaujvaros, Hungary, 2400
    • Szent Pantaleon Korhaz Nonprofit Kft., Idegosztaly
• India
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522 001
      • Lalitha Super Specialities Hospital (P) Ltd.
  • Karnataka
    • Mysore, Karnataka, India, 570004
      • Jagadguru Sri Shivathreeshwara Medical College and Hospital,
  • Maharashtra
    • Pune, Maharashtra, India, 411 011
      • KEM Hospital Research Centre
    • Pune, Maharashtra, India, 411 004
      • Deenanath Mangeshkar Hospital and Research Centre
    • Pune, Maharashtra, India, 411004
      • Sahyadri Speciality Hospital
    • Pune, Maharashtra, India, 411 004
      • Sahyadri Clinical Research & Development Center,
    • Pune, Maharashtra, India, 411030
      • Poona Hospital and Research Centre Department of Neurology
  • NEW Delhi
    • Nehru Nagar, NEW Delhi, India, 110 065
      • Vidyasagar Institute of Mental Health , Neuro& Allied Sciences,
• Malaysia
  • Kelantan Darul Naim, Malaysia
    • Hospital Universiti Sains Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Jabatan Neurosains, Pusat Pengajian Sains Perubatan, Universiti Sains Malaysia.
• Mexico
  • Aguascalientes, Mexico, 20127
    • Instituto Biomedico de Investigacion A. C.
  • DF
    • Delagación Cuauhtemoc, DF, Mexico, 06700
      • Private Office 201
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara Fray Antonio Alcalde
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, CP 64460
      • Hospital Universitario Dr. José Eleuterio González
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Hospital Angeles Culiacan
• Poland
  • Gdansk, Poland, 80-266
    • Indywidualna Specjalistyczna Praktyka Lekarska
  • Krakow, Poland, 31-505
    • Centrum Neurologii Klinicznej Sp. z o. o.
  • Lodz, Poland, 90-148
    • Gabinet Lekarski A. Klimek
  • Swidnik, Poland, 21-040
    • Niepubliczny Zaklad Opieki Zdrowotnej IGNIS dr med. Alicja Lobinska
• Puerto Rico
  • San Juan, Puerto Rico, 00923
    • Epilepsy Control Institute
• Romania
  • Bucuresti, Romania, 010042
    • Cabinet Medical Individual " Dr. Adina Maria Roceanu"
  • Jud. Iasi
    • Iasi, Jud. Iasi, Romania, 700309
      • Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu"
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • Municipal Healthcare Institution City Hospital #5, Neurology Department
  • Kazan, Russian Federation, 420064
    • State Medical Institution Republican Clinical Hospital
  • Moscow, Russian Federation, 107150
    • Central Clinical Hospital #2 N.A. Semashko OAO RZD / Department of Rehabilitation
  • Pyatigorsk, Russian Federation, 357538
    • Pyatigorsk City Hospital #2, Neurology Department,
  • Saint-Petersburg, Russian Federation, 192019
    • State Institution St. Petersburg Psychoneurological Research Institute V.M. Bekhterev of Roszdrav
  • Samara, Russian Federation, 443095
    • Samara Regional Clinical Hospital M.I. Kalinin, Neurology and Neurosurgery Department
• Serbia
  • Belgrade, Serbia, 11 000
    • Institute for Mental Health
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital
• Thailand
  • Bangkok, Thailand, 10400
    • Neurology Division, Department of Medicine, Pramongkutklao College of Medicine
  • Khon Kaen
    • Muang, Khon Kaen, Thailand, 40002
      • Khon Kaen University, Faculty of Medicine, Neurology Unit, Department of Medicine
• United States
  • Alabama
    • Northport, Alabama, United States, 35476
      • Neurology Clinic, PC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Clinic
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials, Inc.
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, Inc.
    • Murrieta, California, United States, 92562
      • Viking Clinic Research Center
    • Murrieta, California, United States, 92562
      • Viking Clinical Research Center
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Temecula, California, United States, 92591
      • Viking Clinical Research Center
  • Florida
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Gainesville, Florida, United States, 32608
      • Optima Neurological Services, LLC
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Sleep Disorders Center of Georgia - Gainesville
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Via Christi Research
    • Wichita, Kansas, United States, 67214
      • VCMA Comprehensive Epilepsy Center
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Associates in Neurology, PSC
  • Maryland
    • Pikesville, Maryland, United States, 21208
      • Mid Atlantic Headache Institute
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists, PA
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Mark A. Fisher, M.D.- Private Practice
    • Oklahoma City, Oklahoma, United States, 73120
      • Veroniqe Sebastian, MD
    • Oklahoma City, Oklahoma, United States, 73135
      • Angelique Barreto, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials of Neurology
    • Temple, Texas, United States, 76508
      • Scott & White Healthcare
    • Temple, Texas, United States, 76502
      • Scott and White Healthcare-Office of Sponsored Research Administration

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
• Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs

Exclusion Criteria:

• Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
• Status epilepticus within one year prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: placebo; matched to the active drug
EXPERIMENTAL: pregabalin CR 330 mg	Drug: pregabalin; Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days; Drug: pregabalin; Controlled Release Tablets, 165 mg, once per day (QD) for 11 days; Drug: pregabalin; Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks); Drug: pregabalin; Controlled Release Tablets, 165 mg, once per day (QD) for 7 days; Drug: pregabalin; Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
EXPERIMENTAL: pregabalin CR 165 mg	Drug: pregabalin; Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days; Drug: pregabalin; Controlled Release Tablets, 165 mg, once per day (QD) for 11 days; Drug: pregabalin; Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks); Drug: pregabalin; Controlled Release Tablets, 165 mg, once per day (QD) for 7 days; Drug: pregabalin; Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.	Week 0 to Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a ≥50% Reduction in the 28-day Partial Seizure Rate From Baseline During the Double-blind Treatment Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder.	Week 0 to Week 14
Percentage Change From Baseline in 28-day Partial Seizure Rate During the Double-blind Treatment Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.	Week 0 to Week 14
Frequency of Secondary Generalized Tonic-clonic Seizures (SGTC) During the Double-blind Treatment Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.	Week 0 to Week 14
Log Transformed 28-day SGTC Rate for All SGTCs During the Double-blind Maintenance Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.	Week 2 to Week 14
Percentage of Participants With ≥50% Reduction in 28-day SGTC Seizure Rate From Baseline During the Double-blind Treatment Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses.	Week 0 to Week 14
Loge 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Maintenance Phase	Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure.	Week 2 to Week 14
Change From Baseline in Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at Week 14	HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 14
Change From Baseline in Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at Week 14	HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.	Baseline, Week 14
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in MOS-SS - Snoring Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in MOS-SS - Awaken Short of Breath or With Headache Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in MOS-SS - Quantity of Sleep (Hours) at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in MOS-SS - Sleep Adequacy Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in MOS-SS - Sleep Somnolence Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in MOS-SS - Sleep Problems Index I Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Problems Index II Score at Week 14	Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 14
Percent of Participants Reporting Optimal Sleep on the MOS-SS - Optimal Sleep Subscale	Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal.	Week 14
Benefit, Satisfaction, and Willingness to Continue Measure (BSW): Benefit From Treatment Question	The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.	Week 14
BSW: Satisfaction From Treatment Question	The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.	Week 14
BSW: Willingness to Continue Question	The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently.	Week 14
Percentage of Participants With New or Intensified Physical Examination Findings During the Double-blind Treatment Phase	Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.	Day 1 to Week 15
Percentage of Participants With New or Intensified Neurological Examination Findings During the Double-blind Treatment Phase	Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait.	Day 1 to Week 15
Percentage of Participants With Self-injurious or Suicidal Ideation or Behavior on Columbia Classification Algorithm of Suicide Assessment (C-CASA)	C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events.	Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)
Percentage of Participants With a Relevant Increase in Sitting Blood Pressure (BP) From Baseline During the Double-blind Treatment Phase	Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema).	Day 1 to Week 15
Percentage of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 450 ms	The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated.	Week 15
Percentage of Participants With Relevant ECG Interval-increases From Baseline During the Double-blind Treatment Phase	The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR.	Week 15
Percentage of Participants With Laboratory Test Abnormalities During the Study	Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen	Day 1 to Week 15

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• French J, Brandt C, Friedman D, Biton V, Knapp L, Pitman V, Chew M, Dubrava S, Posner HB. Adjunctive use of controlled-release pregabalin in adults with treatment-resistant partial seizures: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2014 Aug;55(8):1220-8. doi: 10.1111/epi.12690. Epub 2014 Jun 24.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2011
• Primary Completion (ACTUAL): July 31, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: December 16, 2010
• First Submitted That Met QC Criteria: December 16, 2010
• First Posted (ESTIMATE): December 17, 2010

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: epilepsy; intervention; seizures; placebo-controlled; adjunctive therapy; seizure; partial seizures; Partial epilepsy; controlled-release
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: A0081194; 2010-019035-35 (EUDRACT_NUMBER)