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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
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Of Exeter
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ExeterUnited KingdomUnknown status
Imperial College Healthcare NHS Trust, Charing Cross Hospital
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LondonUnited KingdomUnknown status
National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF
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LondonUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Campus for Ageing & Vitality; Clincal Ageing Research Unit
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NewcastleUnited KingdomUnknown status
Brain Research Center B.V
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AmsterdamNetherlandsUnknown status
UMC St Radboud
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NijmegenNetherlandsUnknown status
Brain Research Center Zwolle
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ZwolleNetherlandsUnknown status
University of Alabama at Birmingham
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BirminghamUnited StatesUnknown status
CenExel Rocky Mountain Clinical Research, LLC
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EnglewoodUnited StatesUnknown status
QUEST Research Institute
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Farmington HillsUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Weill Cornell Medical College
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New YorkUnited StatesUnknown status
Advent Health Orlando
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OrlandoUnited StatesUnknown status
University Pennsylvania Hospital
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PhiladelphiaUnited StatesUnknown status
The Movement Disorder Clinic of Oklahoma
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TulsaUnited StatesUnknown status
Georgetown University
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.