Idiopathic Parkinson´s DiseasePhase 2NCT05931575
Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease
A Phase 2 study testing Fasudil hydrochloride in people with Idiopathic Parkinson´s Disease, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of this phase Ila trial is to provide evidence on safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with early Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Parkinson´s Disease
- What is being tested?
- Fasudil hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 11 Sep 2023to 24 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of at least probable PD according to MDS criteria (Postuma et al. MovDis 2015) and
- Hoehn \& Yahr stage 1 - 3
- must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PD medication for at least 6 weeks
- age: 30 - 80 years
- 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
- Capable of thoroughly understanding all information given and giving full informed consent according to GCP
Who cannot join
- 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
- 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
- Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
- 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
- Patients with an uncontrollable or unstable arterial hypertensive disease (resting blood pressure >180 mmHg systolic and/or >120 mmHg diastolic under current antihypertensive medication)
- Known pulmonary hypertension and any medication prescribed for treatment of pulmonary hypertension
Show all 13Show fewer
- 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
- 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
- Major psychiatric disorder, significant cognitive impairment or clinically evident dementia precluding evaluation of symptoms
- Hypersensitivity to any component of the IMP
- 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
- Pregnant or breast-feeding females or females with childbearing potential, if no adequate contraceptive measures are used
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie
Munich, 81675
About this study
Official title: Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease (ROCK-PD)
The aim of this phase Ila trial is to provide evidence on safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with early Parkinson's disease (PD). Fasudil has shown neuroprotective and pro-regenerative effects, modulated microglial activity and attenuated alpha-synuclein aggregation in PD models in vitro and in vivo. It has been licensed in Japan since 1995 for the treatment of vasospasms and has a beneficial safety profile arguing for its repurposing. Up to 15 trial centers in Germany will recruit patients. Blinded trial medication will be prepared and shipped by the University Pharmacy Leipzig. Fasudil in two dosages or placebo will be administered orally twice daily to 75 early PD patients for a total of 3 weeks. Safety, tolerability and symptomatic efficacy endpoints will be assessed up to 4 weeks after end of treatment. Its well-known safety profile and the lack of disease-modifying treatments for PD justifies its use in patients with early Parkinson's disease. ROCK-PD is a prerequisite for subsequent long-term clinical trials assessing disease-modification in PD in addition to symptomatic efficacy.
- Conditions
- Idiopathic Parkinson´s Disease
- Being tested
- Fasudil hydrochloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasudil hydrochlorideDrug
Also called Fasudil hydrochloride (Fasudil)
Duration of intervention per patient: 22 days; Application scheme: one dose on day 1, two doses on days 2 - 21, one dose on day 22.
PlaceboDrug
Also called Quinine dihydrochloride solution
0.05 ml Quinine dihydrochloride solution (from Quinina Labesfal) in screw flask supplemented with 30 ml Glucose 40% solution from miniplasco directly before use
| Study group | Role | What they receive |
|---|---|---|
| intervention arm (low dose) | Experimental | oral Fasudil solution 88 mg/day (2 x 44 mg) Receives: Drug: Fasudil hydrochloride |
| intervention arm (high dose) | Experimental | oral Fasudil solution 44 mg/day (2 x 22 mg) Receives: Drug: Fasudil hydrochloride |
| Control intervention arm (placebo) | Placebo comparator | oral placebo solution 2x/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined occurrence of intolerance and/or occurrence of self-reported and pre-defined treatment-related SAEs
Combined occurrence of intolerance (termination of treatment because of treatment-related AE) and/or occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs
Measured: from day 1 to day 22
Secondary outcomes (9)
Occurrence of intolerance
Occurrence of intolerance (termination of treatment because of treatment-related AE)
Measured: from day 1 to day 22
Occurrence of self-reported and pre-defined treatment-related SAEs
Occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs
Measured: from day 1 to day 22, and day 1 to day 50
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
the change of MDS-Unified PD Rating Scale (MDS-UPDRS) each part I to IV, min-max: 0-260, 0 indicating no disability and 260 indicating total disability, Part I: Nonmotor experiences of daily living: 13 items. Score range: 0-52; Part II: Motor experiences of daily living: 13 items. Score range: 0-52; Part III: Motor examination: 18 items. Score range: 0-132; Part IV: Motor complications: 6 items. Score range: 0-24; Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
Measured: part I and II from day 1 to day 22, and day 1 to day 50; time frame: part III and IV from day 1 to day 10, day 1 to day 22, and day 1 to day 50
MDS-Unified PD Rating Scale (MDS-UPDRS) score
the change of MDS-Unified PD Rating Scale (MDS-UPDRS) score part I to IV, min-max: 0-260, 0 indicating no disability and 260 indicating total disability, Part I: Nonmotor experiences of daily living: 13 items. Score range: 0-52; Part II: Motor experiences of daily living: 13 items. Score range: 0-52; Part III: Motor examination: 18 items. Score range: 0-132; Part IV: Motor complications: 6 items. Score range: 0-24; Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
Measured: from day 1 to day 22, and day 1 to day 50
Parkinson's Disease Questionnaire (PDQ-8)
the change of 8-item PD Quality of Life Scale (PDQ-8), min-max: 0-32, 0 no and 32 max
Measured: from day 1 to day 22, and day 1 to day 50
Non-Motor Symptom Questionnaire (NMSQuest)
the change of PD Non-Motor Symptom Questionnaire (NMSQuest), min-max: 0-30, 0 no and 30 max
Measured: from day 1 to day 10, day 1 to day 22, and day 1 to day 50
Montreal Cognitive Assessment (MoCA)
the change of Montreal Cognitive Assessment (MoCA), Montreal Cognitive Assessment MoCA: min-max: 0 (worse) -30 (better outcome)
Measured: from day 1 to day 22, and day 1 to day 50
Beck's Depression Inventory II (BDI-II)
the change of Becks depression inventory-II (BDI-II), min-max: 0-63, 0 no and 63 max
Measured: from day 1 to day 22, and day 1 to day 50
Clinician Global Impression of Improvement (CGI-I) and Patient Global Impression of Improvement (PGI-I)
CGI-I [clinician]: min-max: 1-7, min-max: 1 (better) -7 (worse outcome) PGI-I [patient]: min-max: 1-7, min-max: 1 (better) -7 (worse outcome)
Measured: at day 10, 22 and day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start11 Sep 2023
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson´s DiseaseStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Lingor, MD, Principal investigator, Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931575
- Sponsor's protocol ID
- ROCK-PD-0000-LIN-0075-I
- Other IDs
- 01EN2005
- Status last verified
- Sep 2026
- First submitted
- 12 Jun 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolff AW, Bidner H, Remane Y, Zimmer J, Aarsland D, Rascol O, Wyse RK, Hapfelmeier A, Lingor P. Protocol for a randomized, placebo-controlled, double-blind phase IIa study of the safety, tolerability, and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with Parkinson's disease (ROCK-PD). Front Aging Neurosci. 2024 Feb 14;16:1308577. doi: 10.3389/fnagi.2024.1308577. eCollection 2024.
PubMed 38419648
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease (ROCK-PD)
- ClinicalTrials.gov ID
- NCT05931575
- Acronym / sponsor ID
- ROCK-PD-0000-LIN-0075-I
- Conditions
- Idiopathic Parkinson´s Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 24 Aug 2026 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this phase Ila trial is to provide evidence on safety, tolerability and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with early Parkinson's disease (PD). Fasudil has shown neuroprotective and pro-regenerative effects, modulated microglial activity and attenuated alpha-synuclein aggregation in PD models in vitro and in vivo. It has been licensed in Japan since 1995 for the treatment of vasospasms and has a beneficial safety profile arguing for its repurposing. Up to 15 trial centers in Germany will recruit patients. Blinded trial medication will be prepared and shipped by the University Pharmacy Leipzig. Fasudil in two dosages or placebo will be administered orally twice daily to 75 early PD patients for a total of 3 weeks. Safety, tolerability and symptomatic efficacy endpoints will be assessed up to 4 weeks after end of treatment. Its well-known safety profile and the lack of disease-modifying treatments for PD justifies its use in patients with early Parkinson's disease. ROCK-PD is a prerequisite for subsequent long-term clinical trials assessing disease-modification in PD in addition to symptomatic efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention arm (low dose) | Experimental | Drug: Fasudil hydrochlorideoral Fasudil solution 88 mg/day (2 x 44 mg) |
| intervention arm (high dose) | Experimental | Drug: Fasudil hydrochlorideoral Fasudil solution 44 mg/day (2 x 22 mg) |
| Control intervention arm (placebo) | Placebo comparator | Drug: Placebooral placebo solution 2x/day. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of at least probable PD according to MDS criteria (Postuma et al. MovDis 2015) and
- Hoehn \& Yahr stage 1 - 3
- must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PD medication for at least 6 weeks
- age: 30 - 80 years
- 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
Key exclusion criteria (13 listed)
- 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
- 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
- Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
- 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
- Patients with an uncontrollable or unstable arterial hypertensive disease (resting blood pressure >180 mmHg systolic and/or >120 mmHg diastolic under current antihypertensive medication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasudil hydrochlorideAlso: Fasudil hydrochloride (Fasudil)Duration of intervention per patient: 22 days; Application scheme: one dose on day 1, two doses on days 2 - 21, one dose on day 22. | Drug | intervention arm (high dose), intervention arm (low dose) |
| PlaceboAlso: Quinine dihydrochloride solution0.05 ml Quinine dihydrochloride solution (from Quinina Labesfal) in screw flask supplemented with 30 ml Glucose 40% solution from miniplasco directly before use | Drug | Control intervention arm (placebo) |
Primary outcome
Combined occurrence of intolerance and/or occurrence of self-reported and pre-defined treatment-related SAEs
Time frame: from day 1 to day 22
Combined occurrence of intolerance (termination of treatment because of treatment-related AE) and/or occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs
9 secondary outcomes
Occurrence of intolerance
Time frame: from day 1 to day 22
Occurrence of self-reported and pre-defined treatment-related SAEs
Time frame: from day 1 to day 22, and day 1 to day 50
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: part I and II from day 1 to day 22, and day 1 to day 50; time frame: part III and IV from day 1 to day 10, day 1 to day 22, and day 1 to day 50
MDS-Unified PD Rating Scale (MDS-UPDRS) score
Time frame: from day 1 to day 22, and day 1 to day 50
Parkinson's Disease Questionnaire (PDQ-8)
Time frame: from day 1 to day 22, and day 1 to day 50
Non-Motor Symptom Questionnaire (NMSQuest)
Time frame: from day 1 to day 10, day 1 to day 22, and day 1 to day 50
Montreal Cognitive Assessment (MoCA)
Time frame: from day 1 to day 22, and day 1 to day 50
Beck's Depression Inventory II (BDI-II)
Time frame: from day 1 to day 22, and day 1 to day 50
Clinician Global Impression of Improvement (CGI-I) and Patient Global Impression of Improvement (PGI-I)
Time frame: at day 10, 22 and day 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 38419648Wolff AW, Bidner H, Remane Y, Zimmer J, Aarsland D, Rascol O, Wyse RK, Hapfelmeier A, Lingor P. Protocol for a randomized, placebo-controlled, double-blind phase IIa study of the safety, tolerability, and symptomatic efficacy of the ROCK-inhibitor Fasudil in patients with Parkinson's disease (ROCK-PD). Front Aging Neurosci. 2024 Feb 14;16:1308577. doi: 10.3389/fnagi.2024.1308577. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Lingor, MD principal investigator
Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasudil hydrochloride in people with Idiopathic Parkinson´s Disease, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined occurrence of intolerance and/or occurrence of self-reported and pre-defined treatment-related SAEs (time frame: from day 1 to day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.