Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2004-12-31

Brief Summary

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A double-blind, placebo-controlled study to assess the efficacy of adjunctive treatment with LEV 3000mg/day in reducing myoclonic seizures in adolescents and adults suffering from idiopathic generalised epilepsy and to evaluate the safety of LEV in the same population.

Detailed Description

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Conditions

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Generalized Convulsive Epilepsy

Keywords

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Idiopathic Generalized Epilepsy, Myoclonic seizures Keppra - Levetiracetam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Levetiracetam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

References

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Rosenfeld WE, Benbadis S, Edrich P, Tassinari CA, Hirsch E. Levetiracetam as add-on therapy for idiopathic generalized epilepsy syndromes with onset during adolescence: analysis of two randomized, double-blind, placebo-controlled studies. Epilepsy Res. 2009 Jul;85(1):72-80. doi: 10.1016/j.eplepsyres.2009.02.016. Epub 2009 Mar 26.

Reference Type RESULT

PMID: 19327967 (View on PubMed)

Noachtar S, Andermann E, Meyvisch P, Andermann F, Gough WB, Schiemann-Delgado J; N166 Levetiracetam Study Group. Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures. Neurology. 2008 Feb 19;70(8):607-16. doi: 10.1212/01.wnl.0000297512.18364.40.