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Clinical Trials/EUCTR2014-004333-57-Outside-EU/EEA
EUCTR2014-004333-57-Outside-EU/EEA
Active, not recruiting
Not Applicable

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)

CB Japan Co., Ltd.0 sites352 target enrollmentFebruary 10, 2015
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DrugsKeppra

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
CB Japan Co., Ltd.
Enrollment
352
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 10, 2015
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CB Japan Co., Ltd.

Eligibility Criteria

Inclusion Criteria

  • •\- 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
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 12
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 340
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •\- 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)

Outcomes

Primary Outcomes

Not specified

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