Idiopathic Parkinson´s Disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Eril®
Pharmaceutical Form: Oral solution in single-dose container
INN or Proposed INN: Fasudil hydrochloride
CAS Number: 105628-07-7
Other descriptive name: Fasudil hydrochloride
Concentra
Sponsors
Klinikum rechts der Isar der Technischen Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
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 age 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
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 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 XY (calculated by CKD-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the combined safety and tolerability profile of oral Fasudil solution over 22 days;Secondary Objective: • To establish the tolerability profile of oral Fasudil solution over 22 days • To establish the safety profile of oral Fasudil solution over 22 days and until the end of the follow-up period • To establish symptomatic effects of Fasudil on motor and non-motor symptoms in a dose-response relationship (2 Fasudil doses versus placebo): o Motor function assessed by MDS-UPDRS each part I to IV o Motor function assessed by MDS-UPDRS score part I to IV o Quality of life assessed by PDQ-8 o Non-motor function assessed by NMSQuest o Cognitive function assessed by MoCA o Depressive symptoms assessed by BDI-II o Global clinical impression of change assessed by PGI-I/CGI-I ;Primary end point(s): Combined occurrence of intolerance (termination of treatment because of treatment-related AE) and occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22].;Timepoint(s) of evaluation of this end point: from day 1 to day 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Occurrence of intolerance (termination of treatment because of treatment-related AE) [time frame: from day 1 to day 22]. • Occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22, and day 1 to day 50]. • the change of MDS-Unified PD Rating Scale (MDS-UPDRS) each part I to IV [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] • the change of MDS-Unified PD Rating Scale (MDS-UPDRS) score part I to IV • the change of 8-item PD Quality of Life Scale (PDQ-8) [time frame: from day 1 to day 22, and day 1 to day 50] • the change of PD Non-Motor Symptom Questionnaire (NMSQuest) [time frame: from day 1 to day 10, day 1 to day 22, and day 1 to day 50] • the change of Montreal Cognitive Assessment (MoCA) [time frame: from day 1 to day 22, and day 1 to day 50] • the change of Becks depression inventory-II (BDI-II) [time frame: from day 1 to day 22, and day 1 to day 50], • the Global Impression of Improvement score (CGI-I [clinician], PGI-I [patient]) [time point: at day 10, 22 and day 50]. ;Timepoint(s) of evaluation of this end point: • Occurrence of intolerance: from day 1 to day 22 • Occurrence of self-reported and pre-defined treatment-related SAEs: from day 1 to day 22, and day 1 to day 50 • the change of MDS-UPDRS each part I to IV: 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 • the change of MDS-UPDRS score part I to IV • the change of PDQ-8: from day 1 to day 22, and day 1 to day 50 • the change of NMSQuest: from day 1 to day 10, day 1 to day 22, and day 1 to day 50 • the change of MoCA: from day 1 to day 22, and day 1 to day 50 • the change of BDI-II: from day 1 to day 22, and day 1 to day 50 • CGI-I [clinician], PGI-I [patient]: at day 10, 22 and day 50 | — |
Countries
Germany
Contacts
Public ContactHelen Bidner
TUM School of Medicine and Health, Münchner Studienzentrum
Outcome results
None listed