Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00684424
First received: May 22, 2008
Last updated: May 27, 2010
Last verified: May 2010

May 22, 2008
May 27, 2010
July 2008
March 2009   (final data collection date for primary outcome measure)
Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency [ Time Frame: Baseline through Week 16 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00684424 on ClinicalTrials.gov Archive Site
  • Antiepileptic Drugs Used in the Past [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
  • What average dosage of LYRICA has been achieved in NIS study? [ Time Frame: 31Mar09 ] [ Designated as safety issue: No ]
  • What antiepileptic drugs were used in the past? [ Time Frame: 31Mar09 ] [ Designated as safety issue: No ]
  • To assess the change in 28 day partial seizure frequency from baseline visit to final visit. [ Time Frame: 31Mar09 ] [ Designated as safety issue: No ]
  • To assess the seizure freedom. [ Time Frame: 31Mar09 ] [ Designated as safety issue: No ]
  • What concomitant drugs are used? [ Time Frame: 31Mar09 ] [ Designated as safety issue: No ]
  • Did the treatment with Lyrica have to be stop prematurely? [ Time Frame: 31Mar09 ] [ Designated as safety issue: Yes ]
  • All adverse events sholud be recorded. [ Time Frame: 31Mar09 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

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

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

outpatients

Epilepsy
Other: Non-Interventional Study
Observational Only
Outpatients with epilepsy
Intervention: Other: Non-Interventional Study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00684424
A0081213
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2010

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