Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

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WITHDRAWN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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Seletracetam (ucb 44212)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A signed and dated IRB/IEC approved written informed consent form
* Male/female age 18 years (16 years where permitted) to 65 years
* Minimum body weight of 40 kg
* Patients having participated in a previous seletracetam study
* Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.

Exclusion Criteria

* Ongoing psychiatric disease other than mild controlled disorders
* Subject with clinically significant abnormalities in laboratory tests or ECG
* Poor compliance with visit schedule or medication intake in a previous seletracetam study
* Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No