CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 75 target
Drug / intervention
Fasudil hydrochloride +1 moredrug
Likely dose
Placebo 0.05 mlfrom record
Key inclusion· 7
  • ✓Diagnosis of at least probable PD according to MDS criteria
  • ✓Hoehn & Yahr stage 1-3
  • ✓Non-fluctuating with no wearing-off or dyskinesia
  • ✓Stable on symptomatic PD medication for at least 6 weeks
Key exclusion· 15
  • ✕Atypical, secondary Parkinsonian syndromes, or PD mimics
  • ✕History of intracranial bleeding, intracerebral aneurysms, or Moyamoya disease
  • ✕Positive family history of intracranial bleeding, aneurysms, or Moyamoya without imaging confirmation
  • ✕Concomitant life-threatening disease or impairment interfering with functional assessment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT05931575Phase 2ActiveOn Track
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Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease (ROCK-PD)

Technical University of Munich·interventional·Posted Jul 5, 2023·Updated Jun 30, 2026

In Brief

A Phase 2 clinical trial evaluating Fasudil hydrochloride and Placebo for Idiopathic Parkinson´s Disease. Active but no longer recruiting, targeting 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Parkinson´s Disease
CountriesGermany
Collaborators--

Timeline

Phase 2Active
202420252026
First PostedJul 5, 2023
Enrollment StartSep 11, 2023
Primary CompletionSep 30, 2026
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.0 years agoPrimary completion in 3 months

Arms & Interventions

intervention arm (low dose)experimental

oral Fasudil solution 88 mg/day (2 x 44 mg)

Drug: Fasudil hydrochloride
intervention arm (high dose)experimental

oral Fasudil solution 44 mg/day (2 x 22 mg)

Drug: Fasudil hydrochloride
Control intervention arm (placebo)placebo_comparator

oral placebo solution 2x/day.

Drug: Placebo

Interventions

Fasudil hydrochloridedrug

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.

Placebodrug

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