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Parkinson DiseasePhase 1NCT05924243

A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.

A Phase 1 study testing RO7486967 in people with Parkinson Disease, run by Hoffmann-La Roche at 17 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
RO7486967
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
17 sitesin 3 countries
Study dates
22 Sep 2022to 18 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

United States9 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado, 80113

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Weill Cornell Medical College

    New York, New York, 10065

  • Advent Health Orlando

    Orlando, Florida, 32804

  • University Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom5 sites

  • University of Exeter

    Exeter, EX4 4RN

  • Barts Health NHS Trust

    London, E1 2ES

  • Imperial College Healthcare NHS Trust; Charing Cross Hospital

    London, W6 8RF

  • National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF

    London, WC1N 3BG

  • Campus for Ageing & Vitality; Clincal Ageing Research Unit

    Newcastle, NE4 5PL

Other trials in United Kingdom

Netherlands3 sites

  • Brain Research Center B.V

    Amsterdam, 1081 GN

  • UMC St Radboud

    Nijmegen, 6525 GA

  • Brain Research Center Zwolle

    Zwolle, 8025AZ

Other trials in Netherlands

About this study

Official title: 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

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).

Being tested
RO7486967, Placebo
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7486967Drug

    For up to approximately 28 days

  • PlaceboDrug

    For up to approximately 28 days

Study groups in NCT05924243
Study groupRoleWhat they receive
RO7486967 ArmExperimentalParticipants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.
Receives: Drug: RO7486967
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with adverse events (AEs)

    Measured: Up to 45 Days

  2. The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline

    Measured: From Baseline to Up to 45 Days

Secondary outcomes (4)

  1. Time to maximum concentration of RO7486967 in Plasma

    Measured: Day 1, Day 15, and Day 28

  2. Maximum concentration (Cmax) of RO7486967 in Plasma

    Measured: Day 1, Day 15, and Day 28

  3. Area under the curve (AUC) RO7486967 in Plasma

    Measured: Day 1, Day 15, and Day 28

  4. Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET

    Measured: From Baseline to Approximately Day 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2023
  2. Study start22 Sep 2022
  3. Primary completion18 Jul 2024
  4. Study completion18 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05924243
Sponsor's protocol ID
BP43176
Status last verified
Sep 2024
First submitted
21 Jun 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7486967 in people with Parkinson Disease, run by Hoffmann-La Roche at 17 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with adverse events (AEs) (time frame: Up to 45 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05924243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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