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TERMINATEDPHASE2

Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)

NCT00982150•Teva Branded Pharmaceutical Products R&D, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Key Dates

Start Date

September 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

June 1, 2010

Last Updated

August 26, 2013

Enrollment

446

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Talampanel

DRUG

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

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RECRUITING

Intermuscular Coherence as a Biomarker for ALS

NCT05104710

Amyotrophic Lateral Sclerosis

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RECRUITING

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

UPenn Observational Research Repository on Neurodegenerative Disease

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

Control Cohort CTRL COH

ASSESS ALL ALS Study