Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
NCT ID: NCT00353665
Last Updated: 2009-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
63 participants
INTERVENTIONAL
2005-07-31
2009-01-31
Brief Summary
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Detailed Description
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Memantine + riluzole x Placebo + Memantine
Inclusion criteria:
* \< 75 years at disease onset
* \< 3 years of disease progression
* ALS-FRS \> 24
* FVC \> 60
* Probable or definite disease (revised El Escorial criteria)
* No other medical condition
* Normal blood tests
* Regular medication on riluzole \> 1 month
* Nerve conduction studies ruling out conduction block
* EMG with widespread loss of motor units (revised El Escorial criteria)
* At least one hand with ADM strength \> 2 on MRC scale
Duration - 2 years
Evaluation - every 3 months
Primary outcome - ALS-FRS Secondary -SF36, Hamilton depression scale, motor unit number estimation, neurophysiological index, strength (clinical evaluation); side-effects
Intention to treat analysis
60 patients
number estimated for 50% change in decline rate of ALS-FRS
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1 - active
memantine + riluzole
Memantine (Ebixa)
10 mg bid
riluzole
riluzole 50 mg bid
2
riluzole + placebo
riluzole
riluzole 50 mg bid
Placebo
Interventions
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Memantine (Ebixa)
10 mg bid
riluzole
riluzole 50 mg bid
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal blood tests
* Riluzole treatment during 1 month or more
* EMG in accordance with El Escorial criteria
Exclusion Criteria
* Both ADM muscles \< 3 on MRC scale
* Conduction block on nerve conduction tests
* Disease duration \> 3 years
* ALS-FRS \< 25
* Forced vital capacity - \<60%
20 Years
75 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
University of Lisbon
OTHER
Responsible Party
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Instituto de Medicina Molecular
Principal Investigators
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Mamede de Carvalho, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology- Hospital de Santa Maria
Locations
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Department of Neurology - Hospital de Santa Maria
Lisbon, , Portugal
Countries
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Other Identifiers
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002-04
Identifier Type: -
Identifier Source: org_study_id
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