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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

January 18, 2006
October 20, 2011
August 2006
December 2009   (final data collection date for primary outcome measure)
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.
Proportion of patients seizure-free for 6 months during the efficacy assessment phase (excluding dose escalation phase).
Complete list of historical versions of study NCT00280059 on ClinicalTrials.gov Archive Site
  • 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.
Time to exit due to adverse events during the double-blind treatment period (including dose escalation phase). Time to 6-months seizure-freedom after the dose escalation phase. Time to exit due to lack of efficacy after the dose escalation phase. Time to
Not Provided
Not Provided
 
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Epilepsy, Partial
  • Drug: Pregabalin
    dose 150-600 mg/day given BID
  • Drug: Lamotrigine
    dose 100-500 mg/day given BID
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Active Comparator: 2
    Intervention: Drug: Lamotrigine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
April 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Bulgaria,   China,   Colombia,   Czech Republic,   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
 
NCT00280059
A0081046
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP