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

• ClinicalTrials.gov Identifier: NCT00150774
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Last Update Posted: September 17, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Generalized Convulsive Epilepsy	Drug: Levetiracetam	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 116 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Responder rate in myoclonic (type IIB) seizures days over 16 weeks

Secondary Outcome Measures :

1. Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

More Information

Publications of Results:

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.

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.

• ClinicalTrials.gov Identifier: NCT00150774
• Other Study ID Numbers: N166
• First Posted: September 8, 2005
• Last Update Posted: September 17, 2013
• Last Verified: February 2010

Keywords provided by UCB Pharma:

Idiopathic Generalized Epilepsy, Myoclonic seizures; Keppra - Levetiracetam

Additional relevant MeSH terms:

Epilepsy; Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Levetiracetam; Anticonvulsants; Nootropic Agents