Talampanel for Amyotrophic Lateral Sclerosis (ALS)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy, tolerability and safety of oral administration of talampanel compared to a placebo in subjects with ALS.

Official Title
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A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Conditions
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ALS

Intervention / Treatment
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* Drug: Talampanel
* Drug: Talampanel
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. Inclusion Criteria: Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria. Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit. Slow VC test equal to or greater than 70% of the predicted value. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit. Ages 18-80 (inclusive) Exclusion Criteria: The use of invasive or non-invasive ventilation. Subject having undergone gastrostomy. Subject with any clinically significant or unstable medical condition. Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter). Females who are pregnant or nursing.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talampanel 50mg<br>50mg Talampanel 3 times per day | Drug: Talampanel<br>* capsules Talampanel, 3 times per day, 52 weeks<br>* Other names: AMPA antagonist;|
| Experimental: Talampanel 25mg<br>25mg Talampanel 3 times per day | Drug: Talampanel<br>* capsules Talampanel, 3 times per day, 52 weeks<br>* Other names: AMPA antagonist;|
| Placebo Comparator: Placebo<br>placebo 3 times per day | Other: placebo<br>* capsules, placebo, 3 times a day, for 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ALS Functional Rating Score (ALSFRS-R slope) |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS