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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

509

Phase

  • 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

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
Intervention / Treatment
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

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

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

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

October 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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