Actively Recruiting
Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease
Led by Technical University of Munich · Updated on 2026-03-18
75
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of this phase Ila trial is to provide evidence on safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with early Parkinson's disease (PD). Fasudil has shown neuroprotective and pro-regenerative effects, modulated microglial activity and attenuated alpha-synuclein aggregation in PD models in vitro and in vivo. It has been licensed in Japan since 1995 for the treatment of vasospasms and has a beneficial safety profile arguing for its repurposing. Up to 15 trial centers in Germany will recruit patients. Blinded trial medication will be prepared and shipped by the University Pharmacy Leipzig. Fasudil in two dosages or placebo will be administered orally twice daily to 75 early PD patients for a total of 3 weeks. Safety, tolerability and symptomatic efficacy endpoints will be assessed up to 4 weeks after end of treatment. Its well-known safety profile and the lack of disease-modifying treatments for PD justifies its use in patients with early Parkinson's disease. ROCK-PD is a prerequisite for subsequent long-term clinical trials assessing disease-modification in PD in addition to symptomatic efficacy.
CONDITIONS
Official Title
Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with at least probable Parkinson's disease according to MDS criteria
- Hoehn & Yahr stage between 1 and 3
- Non-fluctuating Parkinson's symptoms and stable on symptomatic medication for at least 6 weeks
- Age between 30 and 80 years
- Women of childbearing potential must be non-lactating, surgically sterile, or using effective birth control with a negative pregnancy test
- Capable of understanding all study information and providing informed consent according to GCP
You will not qualify if you...
- Atypical or secondary Parkinsonian syndromes or other conditions that may confuse the diagnosis
- History of intracranial bleeding, cerebral aneurysms, Moyamoya disease, or positive family history without recent imaging confirmation
- Presence of any life-threatening disease or impairment interfering with functional assessment
- Known arterial hypotension or previous hypotensive episodes requiring treatment
- Uncontrolled or unstable arterial hypertension despite medication
- Known pulmonary hypertension or treatment for it
- Confirmed or persistent liver insufficiency or abnormal liver function
- Kidney insufficiency with GFR below 60 ml/min/1.73m²
- Major psychiatric disorder, significant cognitive impairment, or dementia preventing symptom evaluation
- Hypersensitivity to any component of the investigational medicinal product
- Likely non-cooperation or inability to comply with trial requirements
- Pregnant or breastfeeding women or women without adequate contraception
- Participation in another clinical trial with trial medication within the last 12 weeks or five terminal half-lives of that medication or previous participation in this trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie
Munich, Germany, 81675
Actively Recruiting
Research Team
P
Paul Lingor, MD
CONTACT
A
Andreas Wolff, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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