Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
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|ClinicalTrials.gov Identifier: NCT00150813|
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : October 1, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Tonic-clonic||Drug: Levetiracetam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 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 Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.|
|Actual Study Start Date :||August 10, 2005|
|Actual Primary Completion Date :||May 29, 2007|
|Actual Study Completion Date :||May 29, 2007|
Subjects received open-label Levetiracetam.
Pharmaceutical form: oral tablets Route of administration: Oral use
Other Name: Keppra
- Percentage Participants With Treatment Emergent Adverse Events [ Time Frame: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks ]An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
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): NCT00150813
|Ceske Budejovice, Czechia|
|Praha 1, Czechia|
|Praha 5, Czechia|
|Rychnov nad Kneznou, Czechia|
|Study Director:||UCB Cares||001 844 599 2273 (UCB)|