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OpenTrials
Completed

NCT Number: NCT00034814

Multicenter Trial for Adults With Partial Seizures

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Talampanel

Drug

Non-enzyme-inducing TLP 35mg TID

Placebo

Drug

Enzyme-inducing placebo TID

Primary outcomes

  1. Reduction in frequency of partial seizures

    Time frame: 12 weeks

    Change in frequency of recognizable seizures as measured by entries in a seizure diary

Secondary outcomes

  1. The number of seizure-free days and percent responders

    Time frame: 12 weeks

    A responder was defined as a patient with greater than or equal to 50% reduction in seizure frequency compared to baseline

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

Efficacy and Safety of Talampanel as Adjunctive Therapy in Patients With Partial Seizures: A Phase II Clinical Trial.

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
May 3, 2002
Registry last updated
Mar 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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