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

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

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
120
Phase:
Phase 2
Treatment Type:
Drug: Fasudil
Trial Type:
Randomized, parallel assignment
Sponsor:
University Medical Center Goettingen
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
≥65% svc
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
6 months and less than 18 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
yes
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
yes
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Yes

Update Notes:

3/15/2019Recruitment status and locations updated
1/3/2019Trial added

Locations:

University Medical Center Göttingen, Göttingen
Medizinische Hochschule Hannover, Hannover
University of Würzburg, Würzburg

Other Information:

Purpose: 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.
Eligibility: 18 Years and older, all genders, not accepting healthy volunteers
Details:
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 1/3/2019
ClinicalTrials.gov ID: NCT03792490
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov