Status:
COMPLETED
Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)
Lead Sponsor:
University of Lisbon
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into...
Detailed Description
Phase 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset) Memantine + riluzole x Placebo + Memantine Inclusion criteria: * \< 75 years at disease onset * \...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00353665
Start Date
July 1 2005
End Date
January 1 2009
Last Update
April 1 2009
Active Locations (1)
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1
Department of Neurology - Hospital de Santa Maria
Lisbon, Portugal, 1649-028