Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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 the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Lisbon
• Collaborator: H. Lundbeck A/S
• Treatments: Memantine; Riluzole

Criteria

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%