RecruitingPhase 2NCT05931575

Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease

Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease (ROCK-PD)

Sponsor

Technical University of Munich

Enrollment

75 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Idiopathic Parkinson´s Disease

Summary

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.

Eligibility

Min Age: 30 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fasudil — a drug that blocks a protein called ROCK, which is involved in brain cell damage — is safe and can improve symptoms in people with Parkinson's disease who are in the early to mid stages of the condition. **You may be eligible if...** - You have a confirmed diagnosis of Parkinson's disease (probable or confirmed, stages 1–3 on the Hoehn and Yahr scale) - Your symptoms are stable and you are not experiencing fluctuations (no "wearing off" or involuntary movements) - Your Parkinson's medication dose has been stable for at least 6 weeks - You are between 30 and 80 years old **You may NOT be eligible if...** - You have an atypical form of Parkinson's or a look-alike condition - You have a history of brain bleeding, brain aneurysm, or Moyamoya disease - You have low blood pressure or a history of fainting episodes - You have significant liver or kidney problems - You have severe psychiatric illness or dementia - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFasudil hydrochloride

Duration of intervention per patient: 22 days; Application scheme: one dose on day 1, two doses on days 2 - 21, one dose on day 22.

DRUGPlacebo

0.05 ml Quinine dihydrochloride solution (from Quinina Labesfal) in screw flask supplemented with 30 ml Glucose 40% solution from miniplasco directly before use

Locations(1)

Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie

Munich, Germany

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NCT05931575

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