Clinical Study With Lyrica In Patients Suffering From Epilepsy

Completed

• Conditions: Epilepsy; Neuralgia
• Interventions: Drug: Lyrica (pregabalin)

• Registration Number: NCT00922987
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

- Included all adult patients with partial seizures and without contraindications according to Summary of Product Characteristics (SmPC).

Study Timeline

• Study First Submitted: 2009-06-17
• Study First Submitted QC: 2009-06-17
• Study First Posted: 2009-06-18
• Study Start: 2009-09
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-05-31
• Results First Submitted QC: 2011-05-31
• Results First Posted: 2011-06-21
• Status Verified: 2011-07
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Adult patients with partial seizures.

Exclusion Criteria

• Contraindications according to Summary of Product Characteristics (SmPC).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lyrica	Lyrica (pregabalin)	Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency	Baseline through week 16 or early termination (ET)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)	Baseline	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	Week 16 or ET	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.
Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit	Baseline and week 16 or ET	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	Week 4 through week 16 or ET	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	Baseline, week 4 and week 16 or ET	VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety).
Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET	Baseline and week 16 or ET	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇰 Zvolen, Slovakia