Clinical Trial: Pregabalin In Partial Seizures Extension Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial
Brief Summary: To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: Reduction in seizure frequency. [ Time Frame: 18 months ]
Original Primary Outcome: Reduction in seizure frequency.
Current Secondary Outcome:
- Seizure-free patients during each 3-month period [ Time Frame: 18 Months ]
- Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). [ Time Frame: 18 Months ]
- Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). [ Time Frame: 18 Months ]
Original Secondary Outcome:
Information By: Pfizer
Dates:
Date Received: August 31, 2005
Date Started: April 2005
Date Completion:
Last Updated: March 4, 2015
Last Verified: March 2015