A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

Epilepsies, Partial Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam Used as add-on Therapy at Doses of 0.5 to 3 g/Day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280696
• Other study ID #: N01221
• Secondary ID: 2014-004333-57
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2006
• Last updated: February 10, 2015
• Start date: November 2005
• Est. completion date: November 2007

Study information

• Verified date: February 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:

• Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation

• Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit

• Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months

• Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks

Exclusion Criteria:

The following patients are not eligible for inclusion into the study:

• Subjects who were diagnosed with status epilepticus within 3 months before screening

• Subjects with no partial seizures of which frequency was measured during the Baseline Period

• Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study

• Subjects with a history of oral treatment with Levetiracetam (LEV)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• Levetiracetam 250 mg
Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 250 mg Route of Administration: Oral Use
• Levetiracetam 500 mg
Active Substance: Levetiracetam Pharmaceutical Form: Film-coated tablet Concentration: 500 mg Route of Administration: Oral Use

Other:
• Placebo
Active Substance: Placebo Pharmaceutical Form: Film-coated tablet Concentration: 250 mg and 500 mg Route of Administration: Oral Use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Japan Co. Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period		From Baseline to the 12-week Evaluation Period	No
Secondary	Partial (Type I) seizure frequency per week over the Evaluation Period		12-week Evaluation Period	No
Secondary	Partial (Type I) seizure responder rates (50 %, 75 %) over the Evaluation Period		From Baseline to the 12-week Evaluation Period	No
Secondary	Seizure freedom over the Evaluation Period		12-week Evaluation Period	No
Secondary	Categorized percentage reduction from Baseline in partial (Type I) seizure frequency per week over the Evaluation Period		From Baseline to the 12-week Evaluation Period	No
Secondary	Percentage reduction from Baseline in seizure frequency per week by seizure subtype (IA, IB, IC, IA + IB, other) over the Evaluation Period		From Baseline to the 12-week Evaluation Period	No

External Links

•   Clinical Study Summary on UCB.com