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NCT Number: NCT07781644

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Baseline and Week 104

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

    Time frame: Up to at least Week 104

  3. Incidence of Adverse Events (AEs)

    Time frame: Up to at least Week 104

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

    Time frame: Up to at least Week 104

  5. Plasma Concentrations of RO7568282

    Time frame: Up to at least Week 104

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

888-662-6728

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early-stage Parkinson's Disease

Acronym: TARBELA-PD

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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