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Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03792490•University Medical Center Goettingen

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
•Disease duration more than 6 months and less than 24 months (inclusive). Disease onset defined as date of first muscle weakness, excluding fasciculations and cramps
•Vital capacity more than 65% of normal (slow vital capacity; best of three measurements)
•Age: ≥ 18 years
•Patients have to be treated with Riluzole (2 x 50mg/d), must be stable for at least four weeks before randomization
•Patients who have started on Edaravone therapy shall continue Edaravone treatment. Edaravone treatment must not be discontinued for reasons of trial participation.
•Women of childbearing age must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate i.e. less than 1% per year) when used consistently and correct are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
•Capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)
•Patients have to have a valid health insurance, when recruited in a center in France

Exclusion Criteria

•Previous participation in another clinical study involving trial medication within the preceding 12 weeks or five terminal half times of the longest to be eliminated trial medications (whichever is longer) or previous participation in this trial
•Tracheostomy or continuous assisted ventilation of any type during the preceding three months before randomization or a significant pulmonary disorder not attributed to ALS, which may complicate the evaluation of respiratory function, intermittent non-invasive ventilation is permitted,
•Patients with a history of intracranial bleeding, known intracerebral aneurysms or Moyamoya disease, or positive family history for the above. If only family history positive, magnetic resonance (MR)- or x-ray-based cranial imaging not older than 24 months must confirm absence of bleeding, aneurysms or Moyamoya.
•Gastrostomy
•Any medical condition known to have an association with motor neuron dysfunction or involving neuromuscular weakness or another neurodegenerative disease, e.g. Parkinson's disease (PD) or Alzheimer's disease (AD), which might confound or obscure the diagnosis of ALS
•Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
•Patients with known arterial hypotension (resting blood pressure \<90/60 mmHg) or previous hypotensive episodes or requiring treatment for increasing of blood pressure, such as fludrocortisone, midodrine, etilefrine, cafedrine or theodrenaline
•Patients with an uncontrollable or unstable arterial hypertensive disease (resting blood pressure \>180 mmHg systolic and/or \>120 mmHg diastolic under current antihypertensive medication)
•Known pulmonary hypertension and any medication prescribed for treatment of pulmonary hypertension
•Confirmed hepatic insufficiency or abnormal liver function (stable aspartate transaminase (ASAT) and/or alanine aminotransferase (ALAT) greater than 3 times the upper limit of the normal range) and determined to be non-transient through repeat testing
+7 more criteria

Locations (15)

Centre Hospitalier Universitaire Marseille

Marseille, France

Centre Hospitalier Universitaire Montpellier

Montpellier, France

Centre Hospitalier Universitaire Nice

Nice, France

Centre Hospitalier Universitaire Tours

Tours, France

Charité Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

University Medical Center Göttingen

Göttingen, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Jena

Jena, Germany

Key Dates

Start Date

February 20, 2019

Primary Completion Date

November 30, 2022

Completion Date

November 1, 2023

Last Updated

November 30, 2023

Enrollment

120

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Fasudil

DRUG

Placebo

DRUG

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

NCT07322003

Amyotrophic Lateral Sclerosis

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RECRUITING

Intermuscular Coherence as a Biomarker for ALS

NCT05104710

Amyotrophic Lateral Sclerosis

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RECRUITINGNA

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

NCT07357428

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

UPenn Observational Research Repository on Neurodegenerative Disease

Control Cohort CTRL COH

ASSESS ALL ALS Study