Evidence map›Paper›PMID 38419648›Full record

ArticleFrontiers in aging neuroscience2024

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).

Andreas W Wolff, Helen Bidner, Yvonne Remane, Janine Zimmer, Dag Aarsland, Olivier Rascol, Richard K Wyse, Alexander Hapfelmeier, Paul Lingor

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in aging neuroscience, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05931575 (Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients With Parkinson's Disease), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
6.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05931575 phase2active not recruitingnot on this map

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

TypeinterventionalSponsorTechnical University of MunichRan2023 to 2026Enrolled75ConditionsIdiopathic Parkinson´s DiseaseArmsFasudil hydrochloride, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Discovery ofACS bio & med chem Au · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Fasudil inhibits α-synuclein aggregation through ROCK-inhibition-mediated mechanisms.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Article
  13. Article
  14. GRespiratory research · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 4 countries.

Andreas W WolffDepartment of Neurology, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.
Helen BidnerMünchner Studienzentrum (MSZ), School of Medicine, Technical University of Munich, Munich, Germany.
Yvonne RemaneDepartment of Clinical Pharmacy and Drug Safety Center, Leipzig University, Leipzig, Germany.
Janine ZimmerDepartment of Clinical Pharmacy and Drug Safety Center, Leipzig University, Leipzig, Germany.
Dag AarslandDepartment of Old Age Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.
Olivier RascolClinical Investigation Center CIC1436, Departments of Clinical Pharmacology and Neurosciences, University of Toulouse 3, University Hospital of Toulouse, INSERM, Toulouse, France.
Richard K WyseCure Parkinsons, London, United Kingdom.
Alexander HapfelmeierInstitute of AI and Informatics in Medicine, School of Medicine, Technical University of Munich, Munich, Germany.
Paul LingorDepartment of Neurology, Klinikum Rechts der Isar, School of Medicine, Technical University of Munich, Munich, Germany.
Technical University of Munich · DELeipzig University · DEGerman Center for Neurodegenerative Diseases · DEInserm · FRKing's College London · GBParkinson's UK · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The Rho-kinase (ROCK) inhibitor Fasudil has shown symptomatic and disease-modifying effects in Parkinson's disease (PD) models Objectives/design: To investigate the safety, tolerability, and symptomatic efficacy of ROCK-inhibitor Fasudil in comparison to placebo in a randomized, national, multicenter, double-blind phase IIa study in patients with PD. Methods/analysis: We plan to include 75 patients with at least 'probable' PD (MDS criteria), Hoehn and Yahr stages 1-3, and age 30-80 years in 13 German study sites. Patients must be non-fluctuating and their response to PD medication must have been stable for 6 weeks. Patients will be randomly allocated to treatment with the oral investigational medicinal product (IMP) containing either Fasudil in two dosages, or placebo, for a total of 22 days. As primary analysis, non-inferiority of low/high dose of Fasudil on the combined endpoint consisting of occurrence of intolerance and/or treatment-related serious adverse events (SAEs) over 22 days will be assessed in a sequential order, starting with the lower dose. Secondary endpoints will include tolerability alone over 22 days and occurrence of treatment-related SAEs (SARs) over 22 and 50 days and will be compared on group level. Additional secondary endpoints include efficacy on motor and non-motor symptoms, measured on established scales, and will be assessed at several timepoints. Biomaterial will be collected to determine pharmacokinetics of Fasudil and its active metabolite, and to evaluate biomarkers of neurodegeneration. Ethics/registration/discussion: After positive evaluation by the competent authority and the ethics committee, patient recruitment started in the 3rd quarter of 2023. ROCK-PD is registered with Eudra-CT (2021-003879-34) and clinicaltrials.gov (NCT05931575). Results of this trial can pave way for conducting extended-duration studies assessing both symptomatic efficacy and disease-modifying properties of Fasudil.

Indexed as

clinical trialdisease modificationFasudilParkinson’s diseaseROCK inhibitionsafetysymptomatic efficacytolerability

Identifiers

PMID38419648
PMCPMC10899319
OpenAlexW4391818869

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.