Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease (TARBELA-PD)

Roche

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: RO7568282

Study type: Interventional

Funder types: Industry

Identifiers

NCT07781644

2025-524064-37-00 (EU Trial (CTIS) Number)

BP46441

2025

Details and patient eligibility

About

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.

Enrollment: 474 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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474 participants in 3 patient groups, including a placebo group

RO7568282 High Dose

Experimental group

Description:

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

Treatment:

Drug: RO7568282

RO7568282 Low Dose

Experimental group

Description:

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

Treatment:

Drug: RO7568282

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo