Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder and
therapeutic options are limited. The rho kinase (ROCK) inhibitor Fasudil was shown to be
neuroprotective, induced axonal regeneration and improved survival and behavioral outcome in
models of ALS and other neurodegenerative diseases. The aim of this phase IIa, multi-center
and double-blind study is to analyze the safety, tolerability and efficacy of fasudil in two
different doses compared to placebo in approximately 16 trial sites in Germany, France and
Switzerland. Intravenous application of fasudil will be performed in 80 patients and placebo
in 40 patients two times daily for 20 treatment days. The hypothesis is that fasudil is safe
and well-tolerated and its application will significantly improve the clinical outcome in
patients with ALS.