Clinical trial • Phase II • Neurology
fasudil hydrochloride for Idiopathic Parkinson's disease | Parkinson's disease
Phase II trial of fasudil hydrochloride for Idiopathic Parkinson's disease | Parkinson's disease.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Idiopathic Parkinson's disease | Parkinson's disease
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 18-09-2024
- First CTIS Authorization Date
- 30-09-2024
Trial design
ROCK_PD_low_dose (fasudil hydrochloride oral solution; max daily dose 44 mg, max total dose 924 mg, treatment period 22 days) vs ROCK_PD_high_dose (fasudil hydrochloride oral solution; max daily dose 88 mg, max total dose 1848 mg, treatment period 22 days) vs Placebo: Quinina Labesfal 250 mg/ml (quinine dihydrochloride; marketed product; max daily dose 2 [unit 'Other'], max total dose 42; dilution described: 0.05 ml Quinine dihydrochloride with 30 ml 40% glucose solution directly before use).-controlled Phase II trial across 13 sites in Germany.
- Comparator
- ROCK_PD_low_dose (fasudil hydrochloride oral solution; max daily dose 44 mg, max total dose 924 mg, treatment period 22 days) vs ROCK_PD_high_dose (fasudil hydrochloride oral solution; max daily dose 88 mg, max total dose 1848 mg, treatment period 22 days) vs Placebo: Quinina Labesfal 250 mg/ml (quinine dihydrochloride; marketed product; max daily dose 2 [unit 'Other'], max total dose 42; dilution described: 0.05 ml Quinine dihydrochloride with 30 ml 40% glucose solution directly before use).
- Target Sample Size
- 75
- Trial Duration For Participant
- 50
Eligibility
Recruits 75 Vulnerable population selected. Participants must be capable of thoroughly understanding all information given and giving full informed consent according to GCP. No assent or proxy consent procedures are specified in the available record..
- Pregnancy Exclusion
- Pregnant or breast-feeding females or females with childbearing potential, if no adequate contraceptive measures are used
- Vulnerable Population
- Vulnerable population selected. Participants must be capable of thoroughly understanding all information given and giving full informed consent according to GCP. No assent or proxy consent procedures are specified in the available record.
Inclusion criteria
- {"criterion_text":"- Patients with a diagnosis of at least probable PD according to MDS criteria (Postuma et al. MovDis 2015) and\n- Hoehn & Yahr stage 1 – 3\n- must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PD medication for at least 6 weeks\n- age: 30 - 80 years\n- 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\n- Capable of thoroughly understanding all information given and giving full informed consent according to GCP"}
Exclusion criteria
- {"criterion_text":"- 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\n- Hypersensitivity to any component of the IMP\n- 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\n- Pregnant or breast-feeding females or females with childbearing potential, if no adequate contraceptive measures are used\n- 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\n- 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\n- Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment\n- 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\n- Patients with an uncontrollable or unstable arterial hypertensive disease (resting blood pressure >180 mmHg systolic and/or >120 mmHg diastolic under current antihypertensive medication)\n- Known pulmonary hypertension and any medication prescribed for treatment of pulmonary hypertension\n- 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 nontransient through repeat testing\n- Renal insufficiency with a glomerular filtration rate (GFR) <60 ml/min/1,73m² (calculated by MDRD equation) and determined to be non-transient through repeat testing\n- Major psychiatric disorder, significant cognitive impairment or clinically evident dementia precluding evaluation of symptoms"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Combined occurrence of intolerance (termination of treatment because of treatment-related AE) and occurence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22]","definition_or_measurement_approach":"Combined occurrence of intolerance defined as termination of treatment because of treatment-related adverse event (AE) and occurrence of self-reported and pre-defined treatment-related serious adverse events (SAEs); assessed from day 1 to day 22 with laboratory and vital signs included as pre-defined measures."}
Secondary endpoints
- {"endpoint_text":"- Occurrence of intolerance (termination of treatment because of treatment-related AE) [time frame: from day 1 to day 22].","definition_or_measurement_approach":"Occurrence of intolerance defined as termination of treatment due to treatment-related AE; assessed from day 1 to day 22."}
- {"endpoint_text":"- 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].","definition_or_measurement_approach":"Occurrence of self-reported and pre-defined treatment-related SAEs based on laboratory and vital signs; assessed from day 1 to day 22 and day 1 to day 50."}
- {"endpoint_text":"- 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]","definition_or_measurement_approach":"Change from baseline in MDS-UPDRS parts I–IV at specified time frames (part I & II: day 1 to day 22 and day 1 to day 50; part III & IV: day 1 to day 10, day 1 to day 22, and day 1 to day 50)."}
- {"endpoint_text":"- the change of MDS-Unified PD Rating Scale (MDS-UPDRS) score part I to IV","definition_or_measurement_approach":"Change in total and part scores of MDS-UPDRS (parts I–IV) over specified assessment visits."}
- {"endpoint_text":"- 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]","definition_or_measurement_approach":"Change from baseline in PDQ-8 scores assessed from day 1 to day 22 and day 1 to day 50."}
- {"endpoint_text":"- 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]","definition_or_measurement_approach":"Change from baseline in NMSQuest scores at day 10, day 22 and day 50."}
- {"endpoint_text":"- the change of Montreal Cognitive Assessment (MoCA) [time frame: from day 1 to day 22, and day 1 to day 50]","definition_or_measurement_approach":"Change from baseline in MoCA cognitive assessment at day 22 and day 50."}
- {"endpoint_text":"- the change of Becks depression inventory-II (BDI-II) [time frame: from day 1 to day 22, and day 1 to day 50],","definition_or_measurement_approach":"Change from baseline in BDI-II depression scores at day 22 and day 50."}
- {"endpoint_text":"- the Global Impression of Improvement score (CGI-I [clinician], PGI-I [patient]) [time point: at day 10, 22 and day 50].","definition_or_measurement_approach":"Clinician Global Impression of Improvement (CGI-I) and Patient Global Impression of Improvement (PGI-I) assessed at day 10, day 22 and day 50."}
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 41
- Consent Approach
- Participants must be capable of thoroughly understanding all information given and giving full informed consent according to GCP. Subject information and informed consent forms are listed in the documents (L1_SIS_and_ICF variants). No assent, proxy consent procedures, age-specific consent documents or languages are specified in the available record.
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 75
Germany
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 544
- Number Of Sites
- 13
- Number Of Participants
- 75
Sites
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Inga Claus
- Contact Person Email
- inga.claus@ukmuenster.de
- Site Name
- Katholisches Klinikum Bochum gGmbH
- Department Name
- Neurologische Klinik
- Contact Person Name
- Siegfried Muhlack
- Contact Person Email
- siegfried.muhlack@rub.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Neurologie
- Contact Person Name
- Thomas Gasser
- Contact Person Email
- thomas.gasser@med.uni-tuebingen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Björn Falkenburger
- Contact Person Email
- Bjoern.Falkenburger@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Neurologische Klinik und Poliklinik
- Contact Person Name
- Jens Volkmann
- Contact Person Email
- volkmann_j@ukw.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Paul Lingor
- Contact Person Email
- paul.lingor@tum.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Neurologie
- Contact Person Name
- Christoph van Riesen
- Contact Person Email
- christoph.van-riesen@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Institut für Klinische Neurowissenschaften und Medizinische Psychologie
- Contact Person Name
- Alfons Schnitzler
- Contact Person Email
- schnitzA@med.uni-duesseldorf.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Joseph Claßen
- Contact Person Email
- joseph.classen@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinikum für Neurologie
- Contact Person Name
- Daniela Berg
- Contact Person Email
- daniela.berg@uksh.de
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- Klinik und Poliklinik für Neurologie
- Contact Person Name
- Karla Eggert
- Contact Person Email
- eggert@med.uni-marburg.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Molekulare Neurologie, Bewegungsambulanz
- Contact Person Name
- Martin Regensburger
- Contact Person Email
- Martin.Regensburger@uk-erlangen.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Neurologie und Neurophysiologie
- Contact Person Name
- Michel Rijntjes
- Contact Person Email
- michel.rijntjes@uniklinik-freiburg.de
Sponsor
Primary sponsor
- Full Name
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Germany
Investigational products
- Investigational Product Name
- ROCK_PD_low_dose
- Active Substance
- fasudil hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Investigational product (no marketing authorisation listed)
- Dose Levels
- max daily dose 44 mg; max total dose 924 mg; max treatment period 22 days
- Maximum Dose
- 44 mg per day (max daily dose); max total 924 mg
- Investigational Product Name
- ROCK_PD_high_dose
- Active Substance
- fasudil hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Investigational product (no marketing authorisation listed)
- Dose Levels
- max daily dose 88 mg; max total dose 1848 mg; max treatment period 22 days
- Maximum Dose
- 88 mg per day (max daily dose); max total 1848 mg
- Investigational Product Name
- Quinina Labesfal 250 mg/ml Solução injetável
- Active Substance
- quinine dihydrochloride
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Authorised (marketing authorisation in PT: marketingAuthNumber 5506795)
- Dose Levels
- max daily dose 2 (unit 'Other'); max total dose 42; product change description: Dilution (0.05 ml Quinine dihydrochloride with 30 ml 40% glucose solution, directly before use)
- Maximum Dose
- 2 (daily unit 'Other'); max total 42
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