Clinical Trial: Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiraceta

Brief Summary: This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduction during the Treatment Period in PGTC seizure frequency
  • Percentage reduction during the Treatment Period in seizure days
  • Responder rates in PGTC seizure frequency, and in seizure days of all types.
  • The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations


Original Secondary Outcome:

  • Reduction during the Treatment Period in PGTC seizure frequency
  • Percentage reduction during the Treatment Period in seizure days
  • Responder rates in PGTC seizure frequency, and in seizure days of all types.
  • The safety parameters are the following:
  • • Laboratory tests
  • • Adverse events
  • • Electrocardiogram
  • • Physical and neurological examinations


Information By: UCB Pharma

Dates:
Date Received: September 8, 2005
Date Started: September 2001
Date Completion:
Last Updated: November 25, 2013
Last Verified: September 2009