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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00696332 |
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Date of registration:
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10/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Talampanel for Amyotrophic Lateral Sclerosis (ALS)
ALS |
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Scientific 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) |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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559 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00696332 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Hungary
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Israel
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Italy
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Netherlands
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Spain
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United States
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Key inclusion & exclusion 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:
1. Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
2. Subject has experienced his/her first ALS symptoms within 3 years prior to the
screening visit.
3. Slow VC test equal to or greater than 70% of the predicted value.
4. The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
5. Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to
screening visit.
6. Ages 18-80 (inclusive)
Exclusion Criteria:
1. The use of invasive or non-invasive ventilation.
2. Subject having undergone gastrostomy.
3. Subject with any clinically significant or unstable medical condition.
4. Subject participating in any other investigational drug trial or using
investigational drug (within 12 weeks prior to screening and thereafter).
5. Females who are pregnant or nursing.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ALS
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Intervention(s)
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Drug: Talampanel
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Other: placebo
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Primary Outcome(s)
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Change in ALS Functional Rating Score (ALSFRS-R slope)
[Time Frame: 52 weeks]
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Secondary Outcome(s)
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Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation.
[Time Frame: 52 weeks]
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Secondary ID(s)
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ALSTAR
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ALS-TAL-201 (ALSTAR)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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