Clinical Study With Lyrica In Patients Suffering From Epilepsy
Clinical study with Lyrica (pregabalin) in patients suffering from epilepsy. This drug is used as adjunctive therapy with one or more antiepileptics. Lyrica has potential to reduce seizure frequency.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency|
- Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency [ Time Frame: Baseline through week 16 or early termination (ET) ] [ Designated as safety issue: No ]Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit.
- Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit [ Time Frame: Baseline and week 16 or ET ] [ Designated as safety issue: No ]The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit.
- Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study [ Time Frame: Week 4 through week 16 or ET ] [ Designated as safety issue: No ]Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study.
- Change From Baseline in Visual Analog Scale of Anxiety (VAS-A) Scores at Week 4 and Final Visit [ Time Frame: Baseline, week 4 and week 16 or ET ] [ Designated as safety issue: No ]VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
- Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
- Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit [ Time Frame: Week 16 or ET ] [ Designated as safety issue: No ]
The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).
At final visit, the participants CGI-C will be categorized into a three point scale as: 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.
- Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET [ Time Frame: Baseline and week 16 or ET ] [ Designated as safety issue: No ]MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute.
|Study Start Date:||September 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics
Drug: Lyrica (pregabalin)
The daily dose may range from 150mg to 600mg, administered as two single doses. The treatment should be started with 150mg daily dose (2x75mg). Depending on response and tolerability after 7 days may the dose be increased to 300mg/day (2x150mg) and after further 7 days to maximum dose 600mg/day (2x300mg)
- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|