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

Inclusion Criteria:

1. Patients with a diagnosis of at least probable PD according to MDS criteria (Postumaet al. MovDis 2015) and

2. Hoehn & Yahr stage 1 - 3

3. must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PDmedication for at least 6 weeks

4. age: 30 - 80 years

5. Women of childbearing potential must be non-lactating and surgically sterile orusing 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% peryear) when used consistently and correct are for example implants, injectables,combined oral contraceptives, hormonal intrauterine devices (IUDs), sexualabstinence or vasectomized partner

6. Capable of thoroughly understanding all information given and giving full informedconsent according to GCP

Exclusion Criteria:

1. Atypical, secondary Parkinsonian syndromes, PD mimics, or any other medicalcondition known to have an association with Parkinsonian syndromes, which mightconfound or obscure the diagnosis of PD

2. Patients with a history of intracranial bleeding, known intracerebral aneurysms orMoyamoya disease, or positive family history for the above. If only family historypositive, MR- or x-ray-based cranial imaging not older than 24 months must confirmabsence of bleeding, aneurysms, or Moyamoya

3. Presence of any concomitant life-threatening disease or impairment likely tointerfere with functional assessment

4. Patients with known arterial hypotension (resting blood pressure <90/60 mmHg) orprevious hypotensive episodes or requiring treatment for increasing of bloodpressure, such as fludrocortisone, midodrine, etilefrine, cafedrine, ortheodrenaline

5. Patients with an uncontrollable or unstable arterial hypertensive disease (restingblood pressure >180 mmHg systolic and/or >120 mmHg diastolic under currentantihypertensive medication)

6. Known pulmonary hypertension and any medication prescribed for treatment ofpulmonary hypertension

7. Confirmed hepatic insufficiency or abnormal liver function (stable ASAT and/or ALATgreater than 3 times the upper limit of the normal range) and determined to benon-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 benon-transient through repeat testing

9. Major psychiatric disorder, significant cognitive impairment or clinically evidentdementia 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 bythe investigator), or unable to be reached in the case of emergency

12. Pregnant or breast-feeding females or females with childbearing potential, if noadequate contraceptive measures are used

13. Previous participation in another clinical study involving trial medication withinthe preceding 12 weeks or five terminal half times of the longest to be eliminatedtrial medications (whichever is longer) or previous participation in this trial