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Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS — ROCK-ALS  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03792490
Study type Interventional
Source University Medical Center Goettingen
Contact
Status Completed
Phase Phase 2
Start date February 20, 2019
Completion date November 1, 2023
View Details
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