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

This study has been completed.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00150774
First received: September 6, 2005
Last updated: September 16, 2013
Last verified: February 2010
  Purpose

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 Intervention Phase
Generalized Convulsive Epilepsy
Drug: Levetiracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Responder rate in myoclonic (type IIB) seizures days over 16 weeks

Secondary Outcome Measures:
  • Safety and tolerability of levetiracetam by means of AE, laboratory assessments, plasma concentration

Estimated Enrollment: 116
Study Start Date: November 2001
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00150774

Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00150774     History of Changes
Other Study ID Numbers: N166
Study First Received: September 6, 2005
Last Updated: September 16, 2013
Health Authority: Austria: Federal Ministry for Health and Women
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Ireland: Irish Medicines Board
Italy: Ministry of Health
Mexico: National Institute of Public Health, Health Secretariat
New Zealand: Food Safety Authority
Poland: Ministry of Health
Spain: Ministry of Health and Consumption
Switzerland: Swissmedic
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014