Fasudil hydrochloride for Parkinson's (ROCK-PD, NCT05931575)
Oral medication improves movement symptoms
- Trial ID
- NCT05931575
- Official Title
- Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease (ROCK-PD)
- Study Acronym
- ROCK-PD
- Goal
- Oral medication improves movement symptoms
- 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 trial is testing whether the drug fasudil is safe, well tolerated, and helps symptoms in people with early Parkinson's disease. Fasudil is an older medication used in Japan that, in lab and animal studies, showed protective and regenerative effects, reduced inflammation-related activity in the brain, and lessened clumping of a protein linked to Parkinson's; in this study participants will take fasudil by mouth twice a day in one of two doses or a placebo for three weeks, with safety and symptom checks for up to four weeks after treatment. About 75 people aged 30 to 80 with early, mild to moderate Parkinson's (stages 1 to 3) who do not have on/off motor fluctuations or involuntary movements and who have been on stable Parkinson's medication for at least six weeks are being invited to join.
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 trial is testing whether the drug fasudil is safe, well tolerated, and helps symptoms in people with early Parkinson's disease. Fasudil is an older medication used in Japan that, in lab and animal studies, showed protective and regenerative effects, reduced inflammation-related activity in the brain, and lessened clumping of a protein linked to Parkinson's; in this study participants will take fasudil by mouth twice a day in one of two doses or a placebo for three weeks, with safety and symptom checks for up to four weeks after treatment. About 75 people aged 30 to 80 with early, mild to moderate Parkinson's (stages 1 to 3) who do not have on/off motor fluctuations or involuntary movements and who have been on stable Parkinson's medication for at least six weeks are being invited to join.
- 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.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 3 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Treatment is given for a total of 3 weeks, and endpoints will be assessed up to 4 weeks after end of treatment.