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

Epilepsy, Partial Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280059
• Other study ID #: A0081046
• Status: Completed
• Phase: Phase 3
• Start date: August 2006
• Est. completion date: April 2010

Study information

• Verified date: March 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Partial

Intervention

Drug:
• Pregabalin
dose 150-600 mg/day given BID
• Lamotrigine
dose 100-500 mg/day given BID

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brugge
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Leuven
Bulgaria	Pfizer Investigational Site	Plovdiv
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Varna
China	Pfizer Investigational Site	Cheng Du Si Chaun
China	Pfizer Investigational Site	Chongqing
China	Pfizer Investigational Site	Tian Jin
China	Pfizer Investigational Site	Xi'an	Shanxi
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Cali	Valle Del Cauca
Czechia	Pfizer Investigational Site	Brno 2
Czechia	Pfizer Investigational Site	Hradec Kralove
Czechia	Pfizer Investigational Site	Ostrava
Czechia	Pfizer Investigational Site	Pelhrimov
Czechia	Pfizer Investigational Site	Praha 4
Czechia	Pfizer Investigational Site	Rychnov nad Kneznou
Czechia	Pfizer Investigational Site	Zlin
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
Finland	Pfizer Investigational Site	Kuopio
Finland	Pfizer Investigational Site	Tampere
France	Pfizer Investigational Site	Bordeaux Cedex
France	Pfizer Investigational Site	Nancy Cedex
France	Pfizer Investigational Site	Strasbourg Cedex
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Ulm
Germany	Pfizer Investigational Site	Ulm
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Kowloon
Hong Kong	Pfizer Investigational Site	Shatin
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Gyor
Hungary	Pfizer Investigational Site	Nyiregyhaza
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Bangalore
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Indore	Madhya Pradesh
India	Pfizer Investigational Site	Lucknow
India	Pfizer Investigational Site	New Delhi
Ireland	Pfizer Investigational Site	Tallaght	Dublin
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Foggia
Italy	Pfizer Investigational Site	Pisa
Korea, Republic of	Pfizer Investigational Site	Daejeon
Korea, Republic of	Pfizer Investigational Site	Gwangju
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Latvia	Pfizer Investigational Site	Riga
Latvia	Pfizer Investigational Site	Riga
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Vilnius
Lithuania	Pfizer Investigational Site	Vilnius
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	San Luis Potosi
Netherlands	Pfizer Investigational Site	Den Haag	ZH
Norway	Pfizer Investigational Site	Lillehammer
Norway	Pfizer Investigational Site	Trondheim
Portugal	Pfizer Investigational Site	Amadora
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Porto
Portugal	Pfizer Investigational Site	Porto
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Cluj-Napoca	Jud. Cluj
Singapore	Pfizer Investigational Site	Singapore
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Zilina
Spain	Pfizer Investigational Site	Badalona	Barcelona
Spain	Pfizer Investigational Site	Girona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Linkoping
Sweden	Pfizer Investigational Site	Uppsala
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Muang	Khon Kaen
Thailand	Pfizer Investigational Site	Rajthevee	Bangkok
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Liverpool
United Kingdom	Pfizer Investigational Site	Stoke-on-Trent	Staffordshire
United Kingdom	Pfizer Investigational Site	Treliske, Truro, Cornwall

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Bulgaria,  China,  Colombia,  Czechia,  Estonia,  Finland,  France,  Germany,  Hong Kong,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Portugal,  Romania,  Singapore,  Slovakia,  Spain,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 5 up to Week 56
Secondary	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.	Week 4 up to Week 56
Secondary	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.	Week 0 to Week 56
Secondary	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.	Week 0 to Week 56
Secondary	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.	Week 4 up to Week 56
Secondary	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.	Week 4 up to Week 56
Secondary	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.	Week 4 up to Week 56
Secondary	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).	Baseline up to Week 60
Secondary	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).	Baseline up to Week 60
Secondary	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).	Baseline up to Week 60
Secondary	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).	Baseline up to Week 60
Secondary	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.	Month 1 through Month 9 (after 6 months seizure freedom achieved)
Secondary	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.	Month 1 through Month 9 (after 6 months seizure freedom achieved)
Secondary	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.	Month 1 through Month 9 (after 6 months seizure freedom achieved)
Secondary	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.	Month 1 through Month 9 (after 6 months seizure freedom achieved)
Secondary	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.	Week 5 up to Week 56
Secondary	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.	Baseline to Week 56
Secondary	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.	Week 8, Week 32, and Week 56

External Links

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