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Pregabalin Versus Levetiracetam In Partial Seizures

Primary Purpose

Partial Seizures

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
pregabalin
levetiracetam
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Seizures focused on measuring Epilepsies partial, Partial Seizure Disorder, Complex Partial Seizure Disorder, Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

B

A

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Participants With Response to Treatment
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.

Secondary Outcome Measures

Percent Change From Baseline in 28 Day Seizure Frequency at 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.
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
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.
Percentage of Participants Without Seizures
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.
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
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.
Hospital Anxiety and Depression Scale (HADS) Score
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.
Medical Outcomes Study Sleep Scale (MOS-SS) Score
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.
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
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.

Full Information

First Posted
September 27, 2007
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00537238
Brief Title
Pregabalin Versus Levetiracetam In Partial Seizures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Seizures
Keywords
Epilepsies partial, Partial Seizure Disorder, Complex Partial Seizure Disorder, Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Active Comparator
Arm Title
A
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
300, 450, 600 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Intervention Description
1000, 2000, 3000 mg/day administered orally, BID until seizure control/improvement or intolerable side effects
Primary Outcome Measure Information:
Title
Proportion of Participants With Response to Treatment
Description
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.
Time Frame
Baseline up to Week 16
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in 28 Day Seizure Frequency at Week 16
Description
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.
Time Frame
Baseline, Week 16
Title
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
Description
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.
Time Frame
Baseline, Week 16
Title
Percentage of Participants Without Seizures
Description
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.
Time Frame
Baseline up to Week 16
Title
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total and Core Score at Week 7, 10, 13, 16 and Follow-up
Description
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.
Time Frame
Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
Title
Hospital Anxiety and Depression Scale (HADS) Score
Description
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.
Time Frame
Baseline, Week 16
Title
Medical Outcomes Study Sleep Scale (MOS-SS) Score
Description
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.
Time Frame
Baseline, Week 16
Title
Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score
Description
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.
Time Frame
Baseline, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Duffel
ZIP/Postal Code
B-2570
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kyustendil 2500
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Pernik
ZIP/Postal Code
2300
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Ruse 7002
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Montes De Oca
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Brno 2
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Hradec Kralove 3
ZIP/Postal Code
500 03
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Ostrava-Trebovice
ZIP/Postal Code
772 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Pribram 8
ZIP/Postal Code
26195
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Toulouse
ZIP/Postal Code
31043
Country
France
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22083
Country
Germany
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
11521
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Pfizer Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Pfizer Investigational Site
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160 012
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 008
Country
India
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50125
Country
Italy
Facility Name
Pfizer Investigational Site
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Distrito Federal
ZIP/Postal Code
14269
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis Potosi
ZIP/Postal Code
78223
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Panama
Country
Panama
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L 11
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
Pfizer Investigational Site
City
Tondo
State/Province
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Makati City
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
107150
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Donostia
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pfizer Investigational Site
City
Cordoba
ZIP/Postal Code
14008
Country
Spain
Facility Name
Pfizer Investigational Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Pfizer Investigational Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Capa
State/Province
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Cerrahpasa / Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Libertador
ZIP/Postal Code
1010
Country
Venezuela
Facility Name
Pfizer Investigational Site
City
Caracas
State/Province
Miranda
ZIP/Postal Code
1080-A
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
24902473
Citation
Zaccara G, Almas M, Pitman V, Knapp L, Posner H. Efficacy and safety of pregabalin versus levetiracetam as adjunctive therapy in patients with partial seizures: a randomized, double-blind, noninferiority trial. Epilepsia. 2014 Jul;55(7):1048-57. doi: 10.1111/epi.12679. Epub 2014 Jun 5.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081157&StudyName=Pregabalin%20Versus%20Levetiracetam%20In%20Partial%20Seizures
Description
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Pregabalin Versus Levetiracetam In Partial Seizures

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