Pregabalin Versus Levetiracetam In Partial Seizures

January 26, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures

This study will compare pregabalin and levetiracetam in patients with partial seizures. It will also evaluate the safety and tolerability of pregabalin and levetiracetam in these patients.

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.
509

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
      • Duffel, Belgium, B-2570
        • Pfizer Investigational Site
      • Yvoir, Belgium, B-5530
        • Pfizer Investigational Site
  • Bulgaria
      • Kyustendil 2500, Bulgaria
        • Pfizer Investigational Site
      • Pernik, Bulgaria, 2300
        • Pfizer Investigational Site
      • Plovdiv, Bulgaria, 4000
        • Pfizer Investigational Site
      • Ruse 7002, Bulgaria
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1407
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1113
        • Pfizer Investigational Site
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
    • San Jose
      • Montes De Oca, San Jose, Costa Rica
        • Pfizer Investigational Site
  • Czechia
      • Brno, Czechia, 602 00
        • Pfizer Investigational Site
      • Brno 2, Czechia, 602 00
        • Pfizer Investigational Site
      • Hradec Kralove 3, Czechia, 500 03
        • Pfizer Investigational Site
      • Olomouc, Czechia, 775 20
        • Pfizer Investigational Site
      • Ostrava-Trebovice, Czechia, 772 00
        • Pfizer Investigational Site
      • Praha 4, Czechia, 140 59
        • Pfizer Investigational Site
      • Pribram 8, Czechia, 26195
        • Pfizer Investigational Site
      • Rychnov nad Kneznou, Czechia, 516 01
        • Pfizer Investigational Site
  • France
      • Strasbourg Cedex, France, 67091
        • Pfizer Investigational Site
      • Toulouse, France, 31043
        • Pfizer Investigational Site
  • Germany
      • Bonn, Germany, 53105
        • Pfizer Investigational Site
      • Hamburg, Germany, 22083
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 11521
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 57010
        • Pfizer Investigational Site
  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411 004
        • Pfizer Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Pfizer Investigational Site
      • Ludhiana, Punjab, India, 141 008
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50125
        • Pfizer Investigational Site
      • Foggia, Italy, 71100
        • Pfizer Investigational Site
      • Pisa, Italy, 56126
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Pfizer Investigational Site
      • Daejeon, Korea, Republic of, 301-721
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Pfizer Investigational Site
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Pfizer Investigational Site
      • Vilnius, Lithuania, 08661
        • Pfizer Investigational Site
  • Mexico
      • Distrito Federal, Mexico, 14269
        • Pfizer Investigational Site
      • San Luis Potosi, Mexico, 78223
        • Pfizer Investigational Site
  • Panama
      • Panama, Panama
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, L 11
        • Pfizer Investigational Site
      • Lima, Peru, Lima 1
        • Pfizer Investigational Site
  • Philippines
      • Cebu City, Philippines, 6000
        • Pfizer Investigational Site
      • Davao City, Philippines, 8000
        • Pfizer Investigational Site
      • Makati City, Philippines, 1200
        • Pfizer Investigational Site
      • Manila, Philippines, 1000
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1100
        • Pfizer Investigational Site
    • Manila
      • Tondo, Manila, Philippines, 1000
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 125367
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 107150
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 129128
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194354
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 197022
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 194044
        • Pfizer Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Pfizer Investigational Site
      • Barcelona, Spain, 08035
        • Pfizer Investigational Site
      • Cordoba, Spain, 14008
        • Pfizer Investigational Site
      • Girona, Spain, 17007
        • Pfizer Investigational Site
      • Sevilla, Spain, 41071
        • Pfizer Investigational Site
    • Guipuzcoa
      • Donostia, Guipuzcoa, Spain, 20014
        • Pfizer Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Pfizer Investigational Site
      • Taichung, Taiwan, 407
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Cerrahpasa / Istanbul, Turkey, 34098
        • Pfizer Investigational Site
    • Istanbul
      • Capa, Istanbul, Turkey, 34390
        • Pfizer Investigational Site
  • Venezuela
    • Libertador
      • Caracas, Libertador, Venezuela, 1010
        • Pfizer Investigational Site
    • Miranda
      • Caracas, Miranda, Venezuela, 1080-A
        • Pfizer Investigational Site

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects (male or female) must be > 18 years of age, with a diagnosis of epilepsy with partial seizures, as defined in the International League Against Epilepsy (ILAE) classification of seizures.
  • Partial seizures may be simple or complex, with or without secondary tonic-clonic generalization.
  • Subjects must be have been diagnosed with epilepsy for at least 2 years, and must have been unresponsive to treatment with at least two but no more than five prior antiepileptic drugs (AEDs), and at the time of study enrollment are on stable dosages of 1 or 2 standard AEDs.

Exclusion Criteria:

  • Females who are pregnant, breastfeeding, or intend to become pregnant during the course of the trial will be excluded
  • Subjects with other neurologic illness that could impair endpoint assessment, or subjects with Lennox-Gastaut syndrome, absence seizures, status epileptics within the 12 months prior to trial entry, or with seizures due to an underlying medical illness or metabolic syndrome, will be excluded.

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.
Active Comparator: A
Drug: levetiracetam
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Active Comparator: B
Drug: pregabalin
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects

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
Proportion of Participants With Response to Treatment
Time Frame: Baseline up to Week 16
Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28.
Baseline up to Week 16

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
Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
Time Frame: Baseline, Week 16
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline.
Baseline, Week 16
Change From Baseline in the Proportion of 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Rate to 28-day All Partial Seizure Rate at Week 16
Time Frame: Baseline, Week 16
Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures.
Baseline, Week 16
Percentage of Participants Without Seizures
Time Frame: Baseline up to Week 16
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure.
Baseline up to Week 16
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
Time Frame: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment.
Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
Hospital Anxiety and Depression Scale (HADS) Score
Time Frame: Baseline, Week 16
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 16
Medical Outcomes Study Sleep Scale (MOS-SS) Score
Time Frame: Baseline, Week 16
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute.
Baseline, Week 16
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
Time Frame: Baseline, Week 16
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported.
Baseline, Week 16

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

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.
October 1, 2007

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.
May 1, 2012

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.
May 1, 2012

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).
September 27, 2007

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.
September 27, 2007

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.
October 1, 2007

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 28, 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 26, 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.
May 1, 2013

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.
  • A0081157

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.

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