Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
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.