NCT05924243CompletedPhase 1
A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
A Phase 1b, Adaptive, Multi-Center, Randomized, Double Blind, Placebo-Controlled, Parallel Design Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H\&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 21 Jun 2023
- Start date
- 22 Sept 2022
- Primary completion date
- 18 Jul 2024
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Parkinson disease
- NCT number
- NCT05924243
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 60
- From 22 Sept 2022 to the primary completion date, 18 Jul 2024
- 17 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Inclusion Key Criteria:
- Male or post-menopausal female
- Diagnosis of clinically probable idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity)
- A time from diagnosis of PD of at least 3 to maximum 60 months (5 years) at screening
- Modified H\&Y Stage ≤2.5 (in ON state)
- Dopaminergic imaging consistent with dopamine transporter deficit
- "High-affinity binder" or "mixed-affinity binder" genotype for TSPO
- Either treatment naïve or treatment with symptomatic PD therapy (levodopa and/or pramipexole, ropinirole, rotigotine) given for at least 90 days, with stable doses for at least 30 days prior to the first dose
- No anticipated changes in PD therapy throughout the study duration
- SARS-CoV-2 vaccination completed at least 60 days prior to the first dose.
- Exclusion Key Criteria:
- Medical history indicating a Parkinsonian syndrome other than idiopathic PD
- CNS or psychiatric disorders other than idiopathic PD (mild depression or anxiety arising in the context of PD is not exclusionary)
- History of brain surgery for PD
- Use of any of symptomatic drug for PD other than levodopa pramipexole, ropinirole, or rotigotine within 60 days prior to the first dose
- Known carriers for mutations in the following genes: alpha-synuclein, LRRK2, GBA, PRKN, PINK1, or DJ1
- Unstable or clinically significant cardiovascular disease within the last year prior to screening
- Uncontrolled hypertension
- Use of oral anticoagulants, low-molecular-weight heparin, warfarin (Coumadin), acenocoumarol, and phenprocoumon is not allowed within 10 days before the first Lumbar Puncture and during the study (low dose aspirin is permitted as monotherapy)
- Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment that might interfere with the conduct of the study, including but not limited to autoimmune disease, immunodeficiency diseases, any active infectious disease
- History of immunodeficiency diseases
- Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HBcAb), or positive hepatitis C (HCV) at screening
- Vaccine(s) other than SARS-CoV2 vaccine within 28 days prior to the first dose, or plans to receive vaccines during the study or within 28 days of the last dose
- History of chronic liver disease
- Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
- Any previous administration of RO7486967 or other compound targeting NLRP3
- Enrollment in another investigational study
- Use of any of other investigational therapy (other than protocol-mandated study treatment) within 90 days or 5 drug elimination half-lives (whichever is longer) prior to the first dose
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Exeter Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Imperial College Healthcare NHS Trust, Charing Cross Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Campus for Ageing & Vitality; Clincal Ageing Research Unit Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Brain Research Center B.V Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| UMC St Radboud Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Brain Research Center Zwolle Coordinator of this site? Confirm its status | Zwolle | Netherlands | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| CenExel Rocky Mountain Clinical Research, LLC Coordinator of this site? Confirm its status | Englewood | United States | Unknown status |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Advent Health Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| University Pennsylvania Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| The Movement Disorder Clinic of Oklahoma Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.