Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
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|ClinicalTrials.gov Identifier: NCT00291655|
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : November 13, 2009
Last Update Posted : May 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Levetiracetam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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).|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
|Experimental: Levetiracetam (LEV)||
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
- 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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291655
|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)|