A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

NCT ID: NCT00422110

Last Updated: 2012-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Detailed Description

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Conditions

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Epilepsies, Partial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Seletracetam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects from 16 to 70 years old
* Confirmed diagnosis of focal epilepsy
* Partial seizures uncontrolled while taking 1 or 2 AEDs
* At least 8 partial seizures during the 8-week baseline period

Exclusion Criteria

* Seizures occurring only in clusters
* Status epilepticus within 1 year
* Progressive CNS disorder
* Other serious or uncontrolled diseases
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Barbara Bennett, PhD

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

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N01272

Identifier Type: -

Identifier Source: org_study_id

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