Parkinson's Disease
Conditions
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.
Interventions
DRUGRO7568282
RO7568282 will be administered as per the schedule specified in the protocol.
DRUGPlacebo
Placebo will be administered as per the schedule specified in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The Sponsor will also be blinded to treatment assignments.
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Contacts
CONTACTReference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed