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Levetiracetam as Add-on Treatment of Myoclonic Jerks in Adolescents + Adults
This study has been completed.
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00150774
  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 III

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Levetiracetam
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, 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.

Further study details as provided by UCB:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150774

Sponsors and Collaborators
UCB
Investigators
Study Director: Françoise Tonner, MD UCB
  More Information

Study ID Numbers: N166
Study First Received: September 6, 2005
Last Updated: March 7, 2008
ClinicalTrials.gov Identifier: NCT00150774  
Health Authority: Austria: Federal Ministry for Health and Women;   Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Directorate general for the protection of Public health: Medicines;   Canada: Health Canada;   France: Afssaps - French Health Products Safety Agency;   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:
Idiopathic Generalized Epilepsy, Myoclonic seizures
Keppra - Levetiracetam

Study placed in the following topic categories:
Myoclonus
Myoclonus epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases
Dyskinesias
Epilepsies, Myoclonic
Signs and Symptoms
Epilepsy
Neurologic Manifestations
Piracetam
Etiracetam
Epilepsy, Generalized

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009