Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

Status Completed

Clinical Trial 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).

Clinical Trial 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

- < 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00353665
Study type	Interventional
Source	University of Lisbon
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	July 2005
Completion date	January 2009

View Details

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