Information for physicians

The ROCK-PD study is a multicenter, prospective, interventional, randomized, double-blind, placebo-controlled, parallel-group, non-inferiority Phase IIa trial of the safety, tolerability, and symptomatic efficacy of the ROCK inhibitor fasudil in patients with Parkinson's disease.

Study Objectives (excerpt):

Primary Study Objective:

• To investigate the combined safety and/or tolerability profile of oral fasudil solution over 22 days.

Secondary study objectives:

• To investigate the tolerability profile over 22 days.
• To investigate the safety profile over 22 days and until the end of the follow-up period.
  
• To determine the symptomatic effect on motor and non-motor symptoms in a dose-response relationship (2 fasudil doses versus placebo) in MDS-UPDRS, PDQ-8, NMSQuest, MoCA, BDI-II, PGI-I/CGI-I.

Exploratory analyses:

• To determine the pharmacokinetics (fasudil and hydroxyfasudil levels) and pharmacodynamics (ROCK activity) of oral fasudil in patients with PD.
• Collect biomaterial for pre-specified analyses of molecular markers related to disease progression and for future biomarker studies.

Inclusion criteria (excerpt):

• Patients with a diagnosis of at least probable PD according to the MDS criteria (Postuma et al. MovDis 2015)
• Hoehn & Yahr stages 1 - 3
• Must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PD medications for at least 6 weeks
• Age: 30 - 80 years

Exclusion criteria (excerpt):

• Atypical secondary parkinsonian syndromes, PD mimics.
• Patients with intracranial hemorrhage, known intracerebral aneurysms or moyamoya disease or positive family history. If only family history is positive, an MR or radiograph of the skull no older than 24 months must confirm that none of the above conditions are present
• Presence of a life-threatening concomitant disease.
• Patients with arterial hypotension (resting blood pressure <90/60 mmHg) or previous hypotensive episodes or treatment to elevate blood pressure
• Patients with uncontrollable or unstable arterial hypertension (resting blood pressure >180 mmHg systolic and/or >120 mmHg diastolic on current medication)
• Known pulmonary hypertension and any medications used to treat it
• Confirmed hepatic insufficiency or transient abnormal liver function (stable ASAT or ALAT above threefold)
• Renal insufficiency with a glomerular filtration rate (GFR) <60 ml/min/1.73m² and proven to be nontransient
• Severe psychiatric disorder, significant cognitive impairment, or clinically evident dementia
• Hypersensitivity to the study drug
• Pregnant or lactating women or women of childbearing age without adequate contraceptive measures

If you treat patients with Parkinson's disease who are interested in participating in the ROCK-PD study, please feel free to contact our study secretariat. We will refer you and your patients to the nearest study center.