Multicenter Trial for Adults With Partial Seizures

NCT ID: NCT00034814

Last Updated: 2011-03-17

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-01-31

Brief Summary

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To compare seizure frequency in patients with refactory partial seizures (with or without generalization) who are taking Talampanel versus placebo as an add-on therapy to other licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in this group of patients.

Detailed Description

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A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.

Conditions

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Epilepsy

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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1

Enzyme-inducing placebo TID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Enzyme-inducing placebo TID

2

Enzyme-inducing Talampanel 35 mg TID

Group Type EXPERIMENTAL

Talampanel

Intervention Type DRUG

Enzyme-inducing Talampanel 35 mg TID

3

Enzyme-inducing TLP 50mg TID

Group Type EXPERIMENTAL

Talampanel

Intervention Type DRUG

Enzyme-inducing TLP 50mg TID

4

Non-enzyme-inducing placebo TID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Non-enzyme-inducing placebo TID

5

Non-enzyme-inducing TLP 25mg TID

Group Type EXPERIMENTAL

Talampanel

Intervention Type DRUG

Non-enzyme-inducing TLP 25mg TID

6

Non-enzyme-inducing TLP 35mg TID

Group Type EXPERIMENTAL

Talampanel

Intervention Type DRUG

Non-enzyme-inducing TLP 35mg TID

Interventions

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Talampanel

Non-enzyme-inducing TLP 35mg TID

Intervention Type DRUG

Placebo

Enzyme-inducing placebo TID

Intervention Type DRUG

Talampanel

Enzyme-inducing Talampanel 35 mg TID

Intervention Type DRUG

Talampanel

Enzyme-inducing TLP 50mg TID

Intervention Type DRUG

Placebo

Non-enzyme-inducing placebo TID

Intervention Type DRUG

Talampanel

Non-enzyme-inducing TLP 25mg TID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* must weigh greater than or equal to 40kg
* Patients must have diagnosis of partial seizures
* At least 3 observable partial seizures a month
* Are currently being treated with 1 and no more than 2 marketed Anti-epileptic Drugs.

Exclusion:

* Patients on Valproic acid, and Felbamate
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Teva Branded Pharmaceutical Products R&D, Inc.

Other Identifiers

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IXL-201-14-189

Identifier Type: -

Identifier Source: org_study_id

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