Health TrialsbyHealthPanel

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

ConditionParkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorHoffmann-La Roche

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

474 Participants
are divided into 3 treatment groups
Group A: RO7568282 High DoseExperimental treatment 1 intervention
Group B: RO7568282 Low DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: