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
  Purpose

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


Condition Intervention Phase
Epilepsy
Other: Non-Interventional Study
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 199
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Outpatients with epilepsy Other: Non-Interventional Study
Observational Only

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684424

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00684424     History of Changes
Other Study ID Numbers: A0081213
Study First Received: May 22, 2008
Results First Received: March 9, 2010
Last Updated: May 27, 2010
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014