Fasudil (ROCK inhibitor) for safety and symptom relief in early Parkinson's disease

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

This will test whether the ROCK inhibitor fasudil is safe, well tolerated, and helps symptoms in people with early Parkinson's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 30 Years to 80 Years
• Sex: All
• Sponsor: Technical University of Munich (Academic / other)
• Locations: 1 site (Munich)
• Trial ID: NCT05931575 on ClinicalTrials.gov

What this trial studies

This phase 2a trial will give oral fasudil at two dosages or placebo twice daily to 75 patients with early, non-fluctuating Parkinson's disease for three weeks, with follow-up for up to four weeks after treatment. Fasudil is a ROCK inhibitor with preclinical neuroprotective, pro-regenerative, and anti-inflammatory effects and an established safety record from use in Japan for vasospasm. Blinded medication will be prepared centrally by the University Pharmacy Leipzig and patients will be recruited across up to 15 centers in Germany, led by the Technical University of Munich. Primary outcomes focus on safety and tolerability and secondary outcomes measure short-term symptomatic efficacy.

Who should consider this trial

Good fit: Ideal participants are adults aged 30–80 with probable idiopathic Parkinson's disease (Hoehn & Yahr stage 1–3), without motor fluctuations or dyskinesia, and on stable symptomatic medication for at least six weeks.

Not a fit: People with atypical or secondary parkinsonism, motor fluctuations or dyskinesias, unstable PD medications, or outside the 30–80 age range are unlikely to benefit from this trial.

Why it matters

Potential benefit: If fasudil is safe and reduces symptoms, it could offer a repurposed, readily available treatment option and a possible neuroprotective approach for people with early Parkinson's disease.

How similar studies have performed: Preclinical studies show fasudil reduces alpha-synuclein aggregation and modulates microglial activity and the drug has long clinical safety experience for vasospasm, but clinical evidence of benefit in Parkinson's disease is currently limited.

Eligibility criteria

Inclusion Criteria:

1. Patients with a diagnosis of at least probable PD according to MDS criteria (Postuma et al. MovDis 2015) and
2. Hoehn \& Yahr stage 1 - 3
3. must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PD medication for at least 6 weeks
4. age: 30 - 80 years
5. Women of childbearing potential must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are for example implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
6. Capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion Criteria:

1. Atypical, secondary Parkinsonian syndromes, PD mimics, or any other medical condition known to have an association with Parkinsonian syndromes, which might confound or obscure the diagnosis of PD
2. Patients with a history of intracranial bleeding, known intracerebral aneurysms or Moyamoya disease, or positive family history for the above. If only family history positive, MR- or x-ray-based cranial imaging not older than 24 months must confirm absence of bleeding, aneurysms, or Moyamoya
3. Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
4. Patients with known arterial hypotension (resting blood pressure \<90/60 mmHg) or previous hypotensive episodes or requiring treatment for increasing of blood pressure, such as fludrocortisone, midodrine, etilefrine, cafedrine, or theodrenaline
5. Patients with an uncontrollable or unstable arterial hypertensive disease (resting blood pressure \>180 mmHg systolic and/or \>120 mmHg diastolic under current antihypertensive medication)
6. Known pulmonary hypertension and any medication prescribed for treatment of pulmonary hypertension
7. Confirmed hepatic insufficiency or abnormal liver function (stable ASAT and/or ALAT greater than 3 times the upper limit of the normal range) and determined to be non-transient through repeat testing
8. Renal insufficiency with a glomerular filtration rate (GFR) \<60 ml/min/1,73m² (calculated by MDRD equation or byCKD-EPI equation) and determined to be non-transient through repeat testing
9. Major psychiatric disorder, significant cognitive impairment or clinically evident dementia precluding evaluation of symptoms
10. Hypersensitivity to any component of the IMP
11. Liable to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of emergency
12. Pregnant or breast-feeding females or females with childbearing potential, if no adequate contraceptive measures are used
13. Previous participation in another clinical study involving trial medication within the preceding 12 weeks or five terminal half times of the longest to be eliminated trial medications (whichever is longer) or previous participation in this trial

Where this trial is running

Munich

• Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie — Munich, Germany (Recruiting)

Study contacts

• Principal investigator: Paul Lingor, MD — Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie
• Study coordinator: Paul Lingor, MD

Conditions Idiopathic Parkinson´s Disease