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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


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
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