A Phase 2/3 interventional study of Memantine (Ebixa) and riluzole in Amyotrophic Lateral Sclerosis, sponsored by University of Lisbon. Completed at 1 site in Portugal. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-04-01.
Sponsored by University of Lisbon · Phase 2/3, Interventional, and Treatment
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 2/3 trial in ALS patients Double-blinded, parallel, randomized (2 blocs, bulbar/spinal onset)
Memantine + riluzole x Placebo + Memantine
Inclusion criteria:
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
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 63 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →University of Lisbon is the lead sponsor of 38 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
memantine + riluzole
Drug: Memantine (Ebixa) · Drug: riluzole
riluzole + placebo
Drug: riluzole · Drug: Placebo
10 mg bid
Also known as: Ebixa
riluzole 50 mg bid
Also known as: rilutek
ALS-FRS
Time frame: 12 months
QoL, depression scale, strength (clinical evaluation), forced vital capacity
Time frame: 12 months
neurophysiology (motor unit counting, neurophysiological index)
Time frame: 12 months
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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University of Lisbon