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Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

Primary Purpose

Epilepsy, Partial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Lamotrigine
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 Epilepsy, Partial focused on measuring Epilepsy, partial seizures, pregabalin monotherapy, lamotrigine comparator, double-blind and randomized trial

Eligibility Criteria

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

Inclusion Criteria: Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months. Exclusion Criteria: Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin. Primary generalized seizures.

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.

Secondary Outcome Measures

Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures
Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.
Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.
Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.
Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase
Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.
Exit Due to Any Reason After 4-week Dose Escalation Phase
Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.
Time to First Seizure After the 4-Week Dose Escalation Phase
Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.
Median Monthy Seizure Frequency: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Mean Monthy Seizure Frequency: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Median Monthy Seizure Frequency: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Mean Monthy Seizure Frequency: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group
Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.
Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (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; 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 symptoms. Scores relative to start of randomized treatment.
Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.

Full Information

First Posted
January 18, 2006
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
NCT00280059
Brief Title
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
Official Title
A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (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
No

5. Study Description

Brief Summary
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Partial
Keywords
Epilepsy, partial seizures, pregabalin monotherapy, lamotrigine comparator, double-blind and randomized trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
dose 150-600 mg/day given BID
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Intervention Description
dose 100-500 mg/day given BID
Primary Outcome Measure Information:
Title
Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase
Description
Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase.
Time Frame
Week 5 up to Week 56
Secondary Outcome Measure Information:
Title
Time to 6 Consecutive Months of Seizure-freedom After 4-week Dose Escalation Phase: All Seizures
Description
Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis.
Time Frame
Week 4 up to Week 56
Title
Exit Due to Adverse Events During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Description
Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication.
Time Frame
Week 0 to Week 56
Title
Exit for Any Reason During the Double-blind Treatment Phase (Including Dose Escalation Phase)
Description
Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication.
Time Frame
Week 0 to Week 56
Title
Exit Due to Lack of Efficacy After 4-week Dose Escalation Phase
Description
Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication.
Time Frame
Week 4 up to Week 56
Title
Exit Due to Any Reason After 4-week Dose Escalation Phase
Description
Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication.
Time Frame
Week 4 up to Week 56
Title
Time to First Seizure After the 4-Week Dose Escalation Phase
Description
Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication.
Time Frame
Week 4 up to Week 56
Title
Median Monthy Seizure Frequency: All Partial Seizures
Description
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Time Frame
Baseline up to Week 60
Title
Mean Monthy Seizure Frequency: All Partial Seizures
Description
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Time Frame
Baseline up to Week 60
Title
Median Monthy Seizure Frequency: All Seizures
Description
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Time Frame
Baseline up to Week 60
Title
Mean Monthy Seizure Frequency: All Seizures
Description
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation).
Time Frame
Baseline up to Week 60
Title
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
Description
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Time Frame
Month 1 through Month 9 (after 6 months seizure freedom achieved)
Title
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Partial Seizures
Description
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Time Frame
Month 1 through Month 9 (after 6 months seizure freedom achieved)
Title
Median Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Description
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Time Frame
Month 1 through Month 9 (after 6 months seizure freedom achieved)
Title
Mean Monthy Seizure Frequency of Responders for the Months After Achieving 6 Consecutive Months of Seizure Freedom: All Seizures
Description
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom.
Time Frame
Month 1 through Month 9 (after 6 months seizure freedom achieved)
Title
Percentage of Participants Who Achieved at Least 6 Consecutive Months of Seizure Freedom (Responders) by Final Dosage Levels and Treatment Group
Description
Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56.
Time Frame
Week 5 up to Week 56
Title
Change From Baseline to Week 56 in Hospital Anxiety and Depression Scale (HADS)
Description
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; 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 symptoms. Scores relative to start of randomized treatment.
Time Frame
Baseline to Week 56
Title
Medical Outcomes Study Sleep Scale (MOS-SS): Optimal Sleep Subscale
Description
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment.
Time Frame
Week 8, Week 32, and Week 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months. Exclusion Criteria: Treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin. Primary generalized seizures.
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
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Plovdiv
ZIP/Postal Code
4000
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
1309
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1524
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Pfizer Investigational Site
City
Cheng Du Si Chaun
ZIP/Postal Code
610041
Country
China
Facility Name
Pfizer Investigational Site
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Pfizer Investigational Site
City
Tian Jin
ZIP/Postal Code
300052
Country
China
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Brno 2
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Ostrava
ZIP/Postal Code
708 58
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Pelhrimov
ZIP/Postal Code
393 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Pfizer Investigational Site
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Pfizer Investigational Site
City
Nancy Cedex
ZIP/Postal Code
54035
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Pfizer Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hong Kong
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Kowloon
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 054
Country
India
Facility Name
Pfizer Investigational Site
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452001
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Lucknow
ZIP/Postal Code
226 014
Country
India
Facility Name
Pfizer Investigational Site
City
New Delhi
ZIP/Postal Code
110 002
Country
India
Facility Name
Pfizer Investigational Site
City
Tallaght
State/Province
Dublin
ZIP/Postal Code
24
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
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
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Incheon
ZIP/Postal Code
405-760
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
134-701
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
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1038
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
03215
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
San Luis Potosi
ZIP/Postal Code
78223
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Den Haag
State/Province
ZH
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Lillehammer
ZIP/Postal Code
2629
Country
Norway
Facility Name
Pfizer Investigational Site
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Pfizer Investigational Site
City
Amadora
ZIP/Postal Code
2700-276
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Coimbra
ZIP/Postal Code
3040-853 Coimbra
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Cluj-Napoca
State/Province
Jud. Cluj
ZIP/Postal Code
400012
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
11461
Country
Romania
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
04015
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Zilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Pfizer Investigational Site
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Tainan
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Rajthevee
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Stoke-on-Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Treliske, Truro, Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21889410
Citation
Kwan P, Brodie MJ, Kalviainen R, Yurkewicz L, Weaver J, Knapp LE. Efficacy and safety of pregabalin versus lamotrigine in patients with newly diagnosed partial seizures: a phase 3, double-blind, randomised, parallel-group trial. Lancet Neurol. 2011 Oct;10(10):881-90. doi: 10.1016/S1474-4422(11)70154-5. Epub 2011 Aug 31.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081046&StudyName=Study%20Of%20The%20Safety%20And%20Efficacy%20Of%20Lyrica%20In%20The%20Treatment%20Of%20Newly%20Diagnosed%20Partial%20Epilepsy
Description
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Learn more about this trial

Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy

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