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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00280059
First received: January 18, 2006
Last updated: October 20, 2011
Last verified: October 2011
  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:


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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280059

  Show 102 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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: October 20, 2011
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
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 18, 2014