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- TARBELA-PD
Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease
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Neurodegenerative Disorder -
Parkinson's Disease (PD)
- For Medical Professional
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 1/Phase 2
Trial Identifier
NCT07781644, BP46441, 2025-524064-37-00,2025
Condition
Parkinson's Disease
Official 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
Study 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.
Eligibility Criteria
All
≥40 Years & ≤ 85 Years
No
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com