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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00353665 |
Date of registration:
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18/07/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
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Scientific title:
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Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis |
Date of first enrolment:
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July 2005 |
Target sample size:
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63 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00353665 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Mamede de Carvalho, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology- Hospital de Santa Maria |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Definite or probable disease - revise El Escorial criteria
- Normal blood tests
- Riluzole treatment during 1 month or more
- EMG in accordance with El Escorial criteria
Exclusion Criteria:
- Other diseases (such as PNP)
- Both ADM muscles < 3 on MRC scale
- Conduction block on nerve conduction tests
- Disease duration > 3 years
- ALS-FRS < 25
- Forced vital capacity - <60%
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Memantine (Ebixa)
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Drug: Placebo
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Drug: riluzole
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Primary Outcome(s)
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ALS-FRS
[Time Frame: 12 months]
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Secondary Outcome(s)
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neurophysiology (motor unit counting, neurophysiological index)
[Time Frame: 12 months]
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QoL, depression scale, strength (clinical evaluation), forced vital capacity
[Time Frame: 12 months]
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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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