Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease

Sponsor
Hoffmann-La Roche
Study ID
NCT07781644
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • RO7568282 — DRUG
    RO7568282 will be administered as per the schedule specified in the protocol.
  • Placebo — DRUG
    Placebo will be administered as per the schedule specified in the protocol.

Study Details

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 15, 2028
Completion
Apr 15, 2032

Study Design

Enrollment
474 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RO7568282 High Dose
    RO7568282 will be administered as per the schedule specified in the protocol.
  • Experimental: RO7568282 Low Dose
    RO7568282 will be administered as per the schedule specified in the protocol.
  • Placebo Comparator: Placebo
    Placebo will be administered as per the schedule specified in the protocol.

Primary Outcome Measure

Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score [ Time Frame: Up to at least Week 104 ]

Central Contacts

  • Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.
    888-662-6728
    [email protected]
  • Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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