Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00280059
First received: January 18, 2006
Last updated: March 4, 2015
Last verified: March 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy, Partial |
Drug: Pregabalin Drug: Lamotrigine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Seizure-free Participants (Responders) During Efficacy Assessment Phase [ Time Frame: Week 5 up to Week 56 ] [ Designated as safety issue: No ]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 Frame: Week 4 up to Week 56 ] [ Designated as safety issue: No ]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) [ Time Frame: Week 0 to Week 56 ] [ Designated as safety issue: No ]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) [ Time Frame: Week 0 to Week 56 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 4 up to Week 56 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 4 up to Week 56 ] [ Designated as safety issue: No ]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 Frame: Week 4 up to Week 56 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Week 60 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Week 60 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Week 60 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline up to Week 60 ] [ Designated as safety issue: No ]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 [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ] [ Designated as safety issue: No ]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 [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ] [ Designated as safety issue: No ]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 [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ] [ Designated as safety issue: No ]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 [ Time Frame: Month 1 through Month 9 (after 6 months seizure freedom achieved) ] [ Designated as safety issue: No ]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 [ Time Frame: Week 5 up to Week 56 ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline to Week 56 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 8, Week 32, and Week 56 ] [ Designated as safety issue: No ]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.
| Enrollment: | 660 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Pregabalin
dose 150-600 mg/day given BID
|
| Active Comparator: 2 |
Drug: Lamotrigine
dose 100-500 mg/day given BID
|
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00280059
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00280059
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Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00280059 History of Changes |
| Other Study ID Numbers: | A0081046 |
| Study First Received: | January 18, 2006 |
| Results First Received: | December 16, 2010 |
| Last Updated: | March 4, 2015 |
| Health Authority: | United Kingdom: European Medicines Agency |
Keywords provided by Pfizer:
|
Epilepsy partial seizures pregabalin monotherapy lamotrigine comparator double-blind and randomized trial |
Additional relevant MeSH terms:
|
Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Pregabalin Lamotrigine Anticonvulsants Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers |
ClinicalTrials.gov processed this record on September 28, 2016