Recruiting
Phase 2

RO7568282

Sponsor:

Hoffmann-La Roche

Code:

NCT07781644

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

RO7568282

Placebo

Study Details

Brief summary:

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.

Conditions

Parkinson's Disease

Study ID

NCT07781644

Start date

Nov 10, 2026

Status verified date

Nov, 2026

Completion date

Apr 15, 2032

Anticipated

Primary completion date

Dec 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be aged 40 to 85 years inclusive
  • Diagnosis of idiopathic PD
  • Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline
  • Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline
  • Hoehn and Yahr (H\&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline
  • Able to swallow whole capsules

Exclusion Criteria:

  • Medical history indicating a parkinsonian syndrome other than idiopathic PD
  • Diagnosis of PD dementia
  • Diagnosis of a significant neurologic disease other than PD
  • Within the last year, unstable or clinically significant cardiovascular disease
  • Chronic uncontrolled hypertension
  • History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD

Note: Other protocol-defined inclusion/exclusion criteria also apply

Study Design

Enrollment

474 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

RO7568282

RO7568282 will be administered as per the schedule specified in the protocol.

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 and Locations

Central contacts

Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.

888-662-6728global-roche-genentech-trials@gene.com

Locations

Parkinson's Disease and Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.