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

NCT07781644 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: BP464412025-524064-37-002025
• Study Type: interventional
• Target: 474
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score

  Up to at least Week 104

Secondary Outcomes (5)

• Change in Motor Signs From Baseline at Week 104, as Measured by the MDS-UPDRS Part III Score

  Baseline and Week 104

• Time to Worsening of Participants' Motor Function, as Reported by the Participant in the Presence of a Confirmed Motor Progression Event

  Up to at least Week 104

• Incidence of Adverse Events (AEs)

  Up to at least Week 104

• Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)

  Up to at least Week 104

• Plasma Concentrations of RO7568282

  Up to at least Week 104

Study Arms (3)

RO7568282 High Dose

EXPERIMENTAL

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

Drug: RO7568282

RO7568282 Low Dose

EXPERIMENTAL

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

Drug: RO7568282

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RO7568282 DRUG

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

RO7568282 High Dose; RO7568282 Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Sponsor will also be blinded to treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): April 15, 2032
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share