Could a 30-Year-Old blood vessel drug ease Parkinson's?
NCT ID NCT05931575
First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This phase 2 trial tests whether fasudil, a drug already used in Japan for blood vessel spasms, is safe and can help symptoms in people with early Parkinson's disease. 75 participants will take either fasudil or a placebo for 3 weeks. The study focuses on safety and tolerability, with a look at symptom changes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fasudil hydrochloride
- What this could lead to
- If successful, this could point toward a new treatment option to ease symptoms of early Parkinson's disease.
- What could go wrong
- This is a small, early-phase trial (75 people, 3 weeks) focused on safety and tolerability, not proof of effectiveness. The drug may not improve symptoms or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
81 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
-
Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Idiopathic Parkinson´S disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie
Munich, 81675, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.