Evaluation of Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.
Phase 3
Completed
- Conditions
- Seizure Disorder, Partial
- Registration Number
- NCT00150293
- Lead Sponsor
- Pfizer
- Brief Summary
To determine long-term safety and efficacy of pregabalin in patients with partial seizures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
Inclusion Criteria
- Must have met the inclusion criteria for preceding double-blind study
- Have received double-blind study medication and wish to receive open-label pregabalin.
Exclusion Criteria
- Cannot be pregnant or considering becoming pregnant during the course of the study.
- Cannot be receiving any concomitant medication that could alter the effectiveness of the pregabalin response or affect seizure frequency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety Efficacy
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which pregabalin modulates voltage-gated calcium channels in partial seizure patients?
How does pregabalin's efficacy in partial seizures compare to standard-of-care antiepileptic drugs like carbamazepine or lamotrigine in long-term studies?
Are there specific biomarkers or genetic profiles that predict optimal response to pregabalin in patients with focal epilepsy?
What long-term adverse event profiles emerged in NCT00150293 and how were they managed compared to other anticonvulsants?
How does pregabalin's role in seizure management compare to other GABA modulators like gabapentin or benzodiazepines in adjunctive therapy?
Trial Locations
- Locations (1)
Pfizer Investigational Site
Location not specified
Pfizer Investigational Site