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