Clinical Trial: Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

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

Official Title: An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/D

Brief Summary: An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Detailed Summary:
Sponsor: UCB Pharma SA

Current Primary Outcome:

  • Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [ Time Frame: Evaluation Period ]
  • Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [ Time Frame: Evaluation Period ]


Original Primary Outcome: Number and percentage of subjects having at least six months of seizure freedom

Current Secondary Outcome:

  • Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period [ Time Frame: From Visit 1 to the end of the Evaluation Period ]
  • Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period [ Time Frame: From Visit 1 to the end of the Evaluation Period ]
  • Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  • Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  • Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  • Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  • Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations [ Time Frame: Evaluation Period ]
  • Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: Evaluation Period ]


Original Secondary Outcome:

  • • Number and percentage of subjects remaining seizure-free, for all seizures and by seizure type, from the beginning of the trial until the last on-treatment visit.
  • • Safety and tolearbility
  • • Quality of Life


Information By: UCB Pharma

Dates:
Date Received: September 6, 2005
Date Started: November 2001
Date Completion:
Last Updated: March 24, 2015
Last Verified: March 2015