- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160550
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
November 25, 2013 updated by: UCB Pharma
A Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With 3000 mg/Day (Pediatric Target Dose of 60 mg/kg/Day) Oral Levetiracetam (LEV) (166, 250, and 500mg Tablets), in Adult and Pediatric Subjects (4-65 Years) Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic (PGTC) Seizures.
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years) suffering from idiopathic generalized epilepsy uncontrolled despite treatment with one or two concomitant AEDs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
154
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 63 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject with a confirmed diagnosis consistent with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures (IIE) that are classifiable according to the ILAE Classification of Epileptic Seizures.
- Presence of at least 3 PGTC seizures during the 8-week combined Baseline period.
- Absence of brain lesion documented on a CT scan or MRI.
- An EEG performed within 1 year of Visit 1 with features consistent with PGTC seizures or generalized idiopathic epilepsy.
- Male/female subject, >=4 or <=65 years of age at Visit 1.
- Subject on a stable dose of one or two AEDs during baseline.
Exclusion Criteria:
- Previous exposure to levetiracetam.
- History of partial seizures.
- History of convulsive or non-convulsive status epilepticus while taking concomitant AEDs within three months prior to Visit 1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The percentage reduction from the combined Baseline Period in the PGTC seizure frequency per week over the Treatment Period (up-titration + evaluation).
|
Secondary Outcome Measures
Outcome Measure |
---|
Reduction during the Treatment Period in PGTC seizure frequency
|
Percentage reduction during the Treatment Period in seizure days
|
Responder rates in PGTC seizure frequency, and in seizure days of all types.
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The safety parameters are the following: Laboratory tests; Adverse events; Electrocardiogram; Physical and neurological examinations
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Berkovic SF, Knowlton RC, Leroy RF, Schiemann J, Falter U; Levetiracetam N01057 Study Group. Placebo-controlled study of levetiracetam in idiopathic generalized epilepsy. Neurology. 2007 Oct 30;69(18):1751-60. doi: 10.1212/01.wnl.0000268699.34614.d3. Epub 2007 Jul 11.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
November 26, 2013
Last Update Submitted That Met QC Criteria
November 25, 2013
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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