NCT00353665

Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS)

Phase 2-3 - Memantine for Disability in Amyotrophic Lateral Sclerosis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of Lisbon · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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).

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 * \< 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

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Memantine (Ebixa)	10 mg bid
DRUG	riluzole	riluzole 50 mg bid
DRUG	Placebo

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-06-01
• Completion: 2009-01-01
• First posted: 2006-07-19
• Last updated: 2009-04-01

Locations

1 site across 1 country: Portugal