Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With a 50 Percent or Greater Reduction From Baseline in 28 Day Partial Seizure Frequency
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients with partial seizures.
Exclusion Criteria
- •Contraindications according to Summary of Product Characteristics (SmPC).
Arms & Interventions
Lyrica
Adult patients with partial seizures (type of epilepsy). Inclusion criteria according to Summary of Product Characteristics
Intervention: Lyrica (pregabalin) (Drug)
Outcomes
Primary Outcomes
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)
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 Outcomes
- Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S)(Baseline)
- Number of Participants With Change in Clinical Global Impression of Severity (CGI-C) From Baseline at Final Visit(Week 16 or ET)
- Percentage Change From Baseline in 28 Day Partial Seizure Frequency at Final Visit(Baseline and week 16 or ET)
- Number of Participants With no Seizures (Partial or Other) During the Last 4 Weeks in the Study(Week 4 through week 16 or ET)
- 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)
- Change From Baseline in Medical Outcome Study (MOS) Sleep Scale Sub-scores at Week 16 or ET(Baseline and week 16 or ET)