Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).|
- Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase [ Time Frame: during open-label therapy phase of 18 months ] [ Designated as safety issue: Yes ]Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
- Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months [ Time Frame: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
500mg oral tablets,1000 - 3000 mg/day, bid, duration of the study
|Haine St Paul, Belgium|
|Hus (helsinki), Finland|
|Lyon Cedex, France|
|Saint Brieuc, France|
|Saint Quentin, France|
|TOULOUSE Cedex 04, France|
|St Gallen, Switzerland|
|Study Director:||UCB Clinical Trial Call Center||+1 877 822 9493 (UCB)|