Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults
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|ClinicalTrials.gov Identifier: NCT00150774|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 17, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Generalized Convulsive Epilepsy||Drug: Levetiracetam||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam (LEV) (Oral Tablets of 500 mg b.i.d.) at a Dose of 3000 mg/Day as Adjunctive Treatment in Adolescents (≥ 12 Years) and Adults (≤ 65 Years) Suffering From Idiopathic Generalized Epilepsy With Myoclonic Seizures.|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||December 2004|
- Responder rate in myoclonic (type IIB) seizures days over 16 weeks
- Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration
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|Ages Eligible for Study:||12 Years to 65 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Subjects with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing myoclonic seizures (IIB) that are classifiable according to the International Classification of Epileptic Seizures. To ensure an idiopathic generalized epilepsy population, only these subjects with the diagnosis of juvenile myoclonic epilepsy (JME), juvenile absence epilepsy (JAE) or epilepsy with generalized tonic- clonic seizures on awakening must be included.
- Presence of at least eight days with at least one myoclonic seizure (IIB) per day during the eight weeks of the Baseline period.
- Absence of brain lesion documented on a CT scan or MRI; if a CT scan or MRI has not been performed within the past five years before Visit 1, a CT scan (or MRI where legally required) should be performed during the Baseline period.
- Presence of EEG features consistent with idiopathic generalized epilepsy on an EEG recorded during the Baseline period or no more than one year before Visit 1.
- Male/female children ≥ 12 years of age or adult ≤ 65 years of age at Visit 1.
- Subject on a stable dose of one standard anti-epileptic treatment for at least four weeks before Visit 1.
- Previous exposure to levetiracetam.
- History of partial seizures.
- History of convulsive or non-convulsive status epilepticus within 3 months prior to Visit 1.
- Subject taking vigabatrin or tiagabine, subject on felbamate with less than 18 months exposure, and subject under vagal nerve stimulation or ketogenic diet.
- Subject taking any drug (except the concomitant AEDs) with possible CNS effects.
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): NCT00150774
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|
|Other Study ID Numbers:||
|First Posted:||September 8, 2005 Key Record Dates|
|Last Update Posted:||September 17, 2013|
|Last Verified:||February 2010|
Idiopathic Generalized Epilepsy, Myoclonic seizures
Keppra - Levetiracetam
Central Nervous System Diseases
Nervous System Diseases