Reduce motor symptoms with fasudil
- Trial ID
- NCT05931575
- Official Title
- Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease (ROCK-PD)
- Goal
- Reduce motor symptoms with fasudil
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Technical University of Munich
- Study Type
- INTERVENTIONAL
- Enrollment
- 75 participants
- Conditions
- Idiopathic Parkinson´s Disease
- Interventions
- Fasudil hydrochloride, Placebo
Summary For Families
The goal is to test whether blocking ROCK enzymes with fasudil is safe and can reduce neuroinflammation and support dopamine neuron health, which could ease motor symptoms and slow damage in Parkinson's. Fasudil is a ROCK inhibitor that alters cell scaffolding and inflammatory signals to help neurons survive and maintain axons, it is given in addition to usual Parkinson's drugs and does not replace levodopa. The trial is looking for people aged 30 to 80 with probable idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3, who are non‑fluctuating with no wearing-off or dyskinesia and have been on stable PD medication for at least 6 weeks. People with prior intracranial bleeding, uncontrolled blood pressure, serious liver or kidney problems, major psychiatric or cognitive disorders, or pregnancy are excluded.
Locations
- Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie, Munich, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Fasudil hydrochloride. The goal is to test whether blocking ROCK enzymes with fasudil is safe and can reduce neuroinflammation and support dopamine neuron health, which could ease motor symptoms and slow damage in Parkinson's. Fasudil is a ROCK inhibitor that alters cell scaffolding and inflammatory signals to help neurons survive and maintain axons, it is given in addition to usual Parkinson's drugs and does not replace levodopa. The trial is looking for people aged 30 to 80 with probable idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3, who are non‑fluctuating with no wearing-off or dyskinesia and have been on stable PD medication for at least 6 weeks. People with prior intracranial bleeding, uncontrolled blood pressure, serious liver or kidney problems, major psychiatric or cognitive disorders, or pregnancy are excluded.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 3 years and 1 month.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.