Extension Study of Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Study Overview
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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.

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Drug: Talampanel


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talampanel<br>Talampanel 50mg tid | Drug: Talampanel<br>* 50mg capsules tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALSFRS-R |  | every 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs, ECG, Adverse Event Reports |  | every 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Talampanel, Open-Label Study, Amyotrophic Lateral Sclerosis