Trials / Completed
CompletedNCT03792490
Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- University Medical Center Goettingen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fasudil | Fasudil hydrochloride hydrate IV solution |
| DRUG | Placebo | Placebo to Fasudil hydrochloride hydrate, NaCl 0,9% |
Timeline
- Start date
- 2019-02-20
- Primary completion
- 2022-11-30
- Completion
- 2023-11-01
- First posted
- 2019-01-03
- Last updated
- 2023-11-30
Locations
15 sites across 3 countries: France, Germany, Switzerland
Source: ClinicalTrials.gov record NCT03792490. Inclusion in this directory is not an endorsement.