ALSTAR OL: Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00982150

Collaborator

(none)

446

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Drug: Talampanel	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

446 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Talampanel Talampanel 50mg tid	Drug: Talampanel 50mg capsules tid

Arm

Intervention/Treatment

Experimental: Talampanel

Talampanel 50mg tid

Drug: Talampanel

50mg capsules tid

Outcome Measures

Primary Outcome Measures

ALSFRS-R [every 4 weeks]

Secondary Outcome Measures

Vital Signs, ECG, Adverse Event Reports [every 26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.
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.