A randomized, placebo-controlled trial of memantine for functional disability in
amyotrophic lateral sclerosis.
Author(s): de Carvalho M, Pinto S, Costa J, Evangelista T, Ohana B, Pinto A.
Affiliation(s): Neuroscience Department, Hospital de Santa Maria-Centro Hospitalar Lisboa Norte,
Lisbon, Portugal. mamedemg@mail.telepac.pt
Publication date & source: 2010, Amyotroph Lateral Scler. , 11(5):456-60
Our objective is to describe the results of a phase II/III, 12-months,
double-blinded, single-centre, randomized, parallel (1:1), clinical trial
performed to evaluate the efficacy and safety of memantine in ALS. Patients with
probable or definite ALS of less than 36 months disease duration and progression
over a one-month lead-in period were randomly assigned to placebo or memantine at
20 mg/day. The primary endpoint was 12-months ALSFRS decline. Forced vital
capacity, manual muscle testing, visual analogue scale, quality of life, motor
unit number estimation and neurophysiological index were the secondary endpoints.
The number of patients included was based on the assumption of a 50% change in
the ALSFRS decline. Safety and adverse events were evaluated. Sixty-three
patients were included in the trial. Memantine did not show more adverse events
or laboratory changes than placebo. Primary and secondary outcomes were not
different between groups by intention-to-treat and per-protocol analysis. The
most sensitive measurements were neurophysiological, which declined linearly over
time. In conclusion, the results of this study show that memantine is well
tolerated and safe in ALS patients. We did not observe any evidence of efficacy
for memantine but we cannot exclude a positive outcome on survival.
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