A Phase 2 interventional study of Fasudil and Placebo in Amyotrophic Lateral Sclerosis, sponsored by University Medical Center Goettingen. Completed at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by University Medical Center Goettingen · Phase 2, Interventional, and Treatment
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 120 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →University Medical Center Goettingen is the lead sponsor of 61 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Fasudil (Fasudil hydrochloride hydrate IV solution) Dosage form: intravenous, application over 45 minutes Dosage: 30 mg/ day Frequency: 2 x 15 mg Duration of treatment: 20 days
Drug: Fasudil
Fasudil (Fasudil hydrochloride hydrate IV solution) Dosage form: intravenous, application over 45 minutes Dosage: 60 mg/ day Frequency: 2 x 30 mg Duration of treatment: 20 days
Drug: Fasudil
Sodium chloride (NaCl) 0.9% Dosage form: intravenous, application over 45 minutes Dosage: 100 ml Frequency: 2 x Duration of treatment: 20 days Do2 x 1 ml, NaCl 0.9%
Drug: Placebo
Fasudil hydrochloride hydrate IV solution
Placebo to Fasudil hydrochloride hydrate, NaCl 0,9%
Safety (proportion of patients without treatment-related serious adverse events (SAE) up to day 180) and tolerability (proportion of patients without significant drug intolerance during the treatment period)
Primary endpoint is the proportion of patients without significant drug intolerance during the treatment period (tolerability) and the proportion of patients without treatment-related serious adverse events (SAE) up to day 180 (safety).
Time frame: From baseline (day 1) to last follow-up (day 180 ± 5)
Survival time
Time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
ALS Functional Rating Scale (ALSFRS-R)
Amyotrophic lateral sclerosis functional rating scale - revised (ALSFRS-R): a scale to determine different aspects of functionality in patients with ALS, minimum 0 points, maximum 48 points, derived from a questionnaire with 12 questions, each of which can yield up to 4 points, higher score indicates better functionality
Time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
ALS Assessment Questionnaire (ALSAQ-5)
Amyotrophic lateral sclerosis assessment questionnaire (ALSAQ-5): a patient self-report five-item scale to determine the health status and quality of life in patients with ALS, higher scores show worse quality of life
Time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
Edinburgh Cognitive and Behavioral ALS Screen (ECAS)
Edinburgh Cognitive and Behavioral Amyotrophic Lateral Sclerosis Screen (ECAS): a scale to determine the cognitive function of patients with ALS, minimum 0 points, maximum 136 points, higher scores show better cognitive performance
Time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
Motor Unit Number Index (MUNIX)
Motor Unit Number Index (MUNIX): a neurophysiological method based on surface EMG recordings to estimate the number of motor units, higher scores indicate a higher number of motor units
Time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
slow Vital capacity (VC)
Time frame: From baseline (day 1) to end of treatment (day 26 to 30), second follow-up (day 90 ± 4), last follow-up (day 180 ± 5)
Safety (proportion of patients without treatment-related serious adverse events (SAE) up to end of treatment (day 26 to 30)) and tolerability (proportion of patients without significant drug intolerance during the treatment period)
Time frame: From baseline (day 1) to end of treatment (day 26 to 30)
Plan to share: Undecided
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University Medical Center Goettingen