Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.
This was a double-blind, randomized, placebo-controlled, dose ranging study of reldesemtiv in
patients with ALS. Eligible patients were randomized (1:1:1:1) to receive placebo or one of
three doses of reldesemtiv (150, 300, or 450 mg twice daily) for 12 weeks. Randomization was
stratified by riluzole concomitant use/non-use and edaravone concomitant use/non-use.
Concomitant riluzole and edaravone were allowed as long as the riluzole dose had been stable
for at least 30 days prior to screening and edaravone had been taken for 2 cycles prior to
screening; these drugs could not be initiated during the study.
A total of 7 study visits were planned: screening, Day 1 (first dosing day), Weeks 2, 4, 8,
and 12, and follow-up (4 weeks after the last dose of study drug). Study drug (placebo or
reldesemtiv) was to be taken twice daily, approximately 12 hours (± 2 hours) apart and within
2 hours following a meal.
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