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| ID | Type | Description | Link |
|---|---|---|---|
| 01EN2005 | Other Grant/Funding Number | Bundesministerium für Bildung und Forschung (BMBF) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm (low dose) | Experimental | oral Fasudil solution 88 mg/day (2 x 44 mg) |
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| intervention arm (high dose) | Experimental | oral Fasudil solution 44 mg/day (2 x 22 mg) |
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| Control intervention arm (placebo) | Placebo Comparator | oral placebo solution 2x/day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasudil hydrochloride | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | from day 1 to day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of intolerance | Occurrence of intolerance (termination of treatment because of treatment-related AE) | from day 1 to day 22 |
| Occurrence of self-reported and pre-defined treatment-related SAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Lingor, MD | Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technische Universität München, Klinikum rechts der Isar, Klinik und Poliklinik für Neurologie | Munich | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38419648 | Derived | 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. |
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| ID | Term |
|---|---|
| C049347 | fasudil |
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| Placebo | Drug | 0.05 ml Quinine dihydrochloride solution (from Quinina Labesfal) in screw flask supplemented with 30 ml Glucose 40% solution from miniplasco directly before use |
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Occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs
| 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). | 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). | 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 | 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 | 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) | 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 | 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) | at day 10, 22 and day 50 |