Actively Recruiting

Phase 2
Age: 30Years - 80Years
All Genders
ID05931575

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

Led by Technical University of Munich · Updated on 2026-03-18

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and symptom relief effects of the ROCK-inhibitor Fasudil in patients with early Parkinson's disease. Fasudil has shown potential neuroprotective and regenerative effects in laboratory and animal models, with a favorable safety record from its use in treating vasospasms in Japan. This phase IIa trial aims to gather evidence to support future long-term studies focused on disease modification and symptom management in Parkinson's disease. The trial randomly assigns 75 patients to receive one of three oral treatments twice daily for 3 weeks: a high dose of Fasudil (88 mg/day), a low dose of Fasudil (44 mg/day), or a placebo solution. The dosing schedule includes one dose on day 1, two doses daily from days 2 to 21, and a final dose on day 22. The blinded medication is prepared and shipped by the University Pharmacy Leipzig, and the study is conducted across up to 15 centers in Germany. Participants will be monitored during treatment and for 4 weeks after to assess safety, tolerability, and symptom changes. Evaluations include tracking adverse events, Parkinson's disease rating scales, depression inventories, cognitive assessments, and patient and clinician impressions of improvement. These assessments occur at multiple time points from treatment start to day 50, supporting a comprehensive review of Fasudil's impact over the short term. The total participation duration spans about 7 weeks from treatment initiation to final follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with at least probable Parkinson's disease according to Movement Disorder Society criteria
  • Hoehn & Yahr stage 1 to 3
  • Stable on Parkinson's disease medication without wearing-off or dyskinesia for at least 6 weeks
  • Aged between 30 and 80 years
  • Women of childbearing potential must be non-lactating, surgically sterile, or using effective birth control and have a negative pregnancy test
  • Able to understand study information and give informed consent according to Good Clinical Practice
Not Eligible

You will not qualify if you...

  • Atypical or secondary Parkinsonian syndromes, Parkinson's disease mimics, or other medical conditions that could confuse diagnosis
  • History of intracranial bleeding, cerebral aneurysms, Moyamoya disease, or positive family history unless recent imaging confirms absence
  • Any life-threatening illness or impairment affecting functional assessment
  • Known low blood pressure (below 90/60 mmHg) or previous hypotensive episodes requiring treatment
  • Uncontrolled high blood pressure despite medication (above 180/120 mmHg)
  • Pulmonary hypertension or medication for it
  • Liver insufficiency or abnormal liver tests exceeding three times normal levels
  • Kidney insufficiency with reduced filtration rate below 60 ml/min/1.73m²
  • Major psychiatric disorders, significant cognitive impairment, or dementia preventing symptom evaluation
  • Hypersensitivity to study medication components
  • Unlikely to comply with trial requirements or unreachable in emergencies
  • Pregnant, breastfeeding, or women not using adequate contraception
  • Participation in another clinical trial with medication within the last 12 weeks or five half-lives of the medication

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 22 days

Participants receive oral Fasudil or placebo according to assigned dose schedules.

Daily dosing with one dose on day 1, two doses on days 2 to 21, and one dose on day 22

Follow-up

Duration - Up to 28 days after treatment

Participants are monitored for safety, tolerability, and symptom changes after treatment ends.

Visits at day 22 and day 50

Trial Site Locations

Total: 1 location

1

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

Munich, Germany, 81675

Actively Recruiting

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Research Team

P

Paul Lingor, MD

A

Andreas Wolff, MD

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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Published Research Related To This Trial

Protocol for a randomized, placebo-controlled, double-blind phase IIa study of the safety, tolerability, and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with Parkinson's disease (ROCK-PD).

Andreas W Wolff, Helen Bidner, Yvonne Remane...

https://pubmed.ncbi.nlm.nih.gov/38419648