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Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

NCT ID: NCT00982150

Last Updated: 2013-08-26

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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Talampanel Open-Label Study Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Talampanel

Talampanel 50mg tid

Group Type EXPERIMENTAL

Talampanel

Intervention Type DRUG

50mg capsules tid

Interventions

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Talampanel

50mg capsules tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
* Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.

Exclusion Criteria

* Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
* Patients using any of the following:

* Chronic use of lithium carbonate
* Chronic use of mecasermin (rhIGF-1)
* Chronic use of minocycline
* Chronic use of more than 600mg/day coenzyme Q10
* Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
* Patients participating in any other investigational drug study and use of any other investigational drug
* Patients taking drugs that may interact with Talampanel
* Females who are pregnant or nursing.
* Females of child-bearing potential who do not practice medically acceptable methods of contraception.
* Any condition of the patient which the investigator feels may interfere with participation in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Responsibility Role SPONSOR

Countries

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Belgium Canada France Germany Hungary Israel Italy Netherlands Spain United States

Other Identifiers

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ALS-TAL-201-OL

Identifier Type: -

Identifier Source: org_study_id