Parkinson's DiseasePhase 1/2TARBELA-PDNCT07781644
Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease
A Phase 1/2 study testing RO7568282 in people with Parkinson's Disease, run by Hoffmann-La Roche at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- RO7568282
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 474 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Sep 2026to 15 Apr 2032
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
United Kingdom2 sites
Ninewells Hospital, Dundee- Scotland
Dundee, DD2 1SY
Royal London Hospital
London, E1 1FR
About this study
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
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
- Being tested
- RO7568282, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7568282Drug
RO7568282 will be administered as per the schedule specified in the protocol.
PlaceboDrug
Placebo will be administered as per the schedule specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7568282 High Dose | Experimental | RO7568282 will be administered as per the schedule specified in the protocol. Receives: Drug: RO7568282 |
| RO7568282 Low Dose | Experimental | RO7568282 will be administered as per the schedule specified in the protocol. Receives: Drug: RO7568282 |
| Placebo | Placebo comparator | Placebo will be administered as per the schedule specified in the protocol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score
Measured: 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
Measured: 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
Measured: Up to at least Week 104
Incidence of Adverse Events (AEs)
Measured: Up to at least Week 104
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Measured: Up to at least Week 104
Plasma Concentrations of RO7568282
Measured: Up to at least Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781644
- Sponsor's protocol ID
- BP46441
- Other IDs
- 2025-524064-37-00, 2025
- Acronym
- TARBELA-PD
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing