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Trial record 1 of 1 for:    NCT00684424
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Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

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ClinicalTrials.gov Identifier: NCT00684424
Recruitment Status : Completed
First Posted : May 26, 2008
Results First Posted : June 24, 2010
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date May 22, 2008
First Posted Date May 26, 2008
Results First Submitted Date March 9, 2010
Results First Posted Date June 24, 2010
Last Update Posted Date June 24, 2010
Study Start Date July 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2010)
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency [ Time Frame: Baseline through Week 16 ]
Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
Original Primary Outcome Measures
 (submitted: May 22, 2008)
The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase, [ Time Frame: 31Mar09 ]
Change History
Current Secondary Outcome Measures
 (submitted: May 27, 2010)
  • Antiepileptic Drugs Used in the Past [ Time Frame: Baseline ]
    Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.
  • Change in 28 Day Partial Seizure Frequency [ Time Frame: Baseline through Week 16 (Final Visit ) ]
    Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.
  • Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study [ Time Frame: Week 8 up to Week 16 (Last 4 weeks of the treatment period) ]
    Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.
  • Concomitant Drug Treatments [ Time Frame: Baseline through Week 16 (Final Visit) ]
    Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.
  • Average Dosage of Pregabalin Taken at Baseline and Final Visit [ Time Frame: Baseline, Week 16 (Final Visit ) ]
    Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.
  • Visual Analog Scale of Anxiety (VAS-A) [ Time Frame: Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward ]
    Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.
  • Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A) [ Time Frame: Baseline, Week 16 (Final Visit), Last Observation Carried Forward ]
    Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.
  • Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ]
    CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.
  • Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C) [ Time Frame: Week 16 (Final Visit) ]
    CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.
  • Medical Outcomes Sleep Scale (MOS-S) [ Time Frame: Baseline, Week 16 (Final Visit ) ]
    MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
  • Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale [ Time Frame: Baseline, Week 16 (Final Visit) ]
    MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.
Original Secondary Outcome Measures
 (submitted: May 22, 2008)
  • What average dosage of LYRICA has been achieved in NIS study? [ Time Frame: 31Mar09 ]
  • What antiepileptic drugs were used in the past? [ Time Frame: 31Mar09 ]
  • To assess the change in 28 day partial seizure frequency from baseline visit to final visit. [ Time Frame: 31Mar09 ]
  • To assess the seizure freedom. [ Time Frame: 31Mar09 ]
  • What concomitant drugs are used? [ Time Frame: 31Mar09 ]
  • Did the treatment with Lyrica have to be stop prematurely? [ Time Frame: 31Mar09 ]
  • All adverse events sholud be recorded. [ Time Frame: 31Mar09 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Official Title Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Brief Summary The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population outpatients
Condition Epilepsy
Intervention Other: Non-Interventional Study
Observational Only
Study Groups/Cohorts Outpatients with epilepsy
Intervention: Other: Non-Interventional Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2009)
199
Original Estimated Enrollment
 (submitted: May 22, 2008)
200
Actual Study Completion Date March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age over 18 years old, patients with epilepsia with partial seizures
  • Enrollment to study is fully on physician decision in compliance with current SPC.

Exclusion Criteria:

  • Patient who did not meet indication according to SPC Lyrica
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00684424
Other Study ID Numbers A0081213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2010