What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, dopamine agonists, and cholinesterase inhibitors. Levodopa can cause nausea, somnolence, dizziness, headache, and more serious effects like confusion, hallucinations, and orthostatic hypotension. Dopamine agonists, such as pramipexole and ropinirole, may lead to side effects like edema, somnolence, constipation, dizziness, hallucinations, and nausea. Cholinesterase inhibitors, used for cognitive impairment in PD, can cause worsened tremor, nausea, and vomiting. These side effects should be monitored and managed in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on dopaminergic therapies. Levodopa, often combined with carbidopa, remains the cornerstone of treatment, helping to replenish dopamine levels. Dopamine agonists such as pramipexole, ropinirole, and rotigotine mimic dopamine's effects in the brain. MAO B inhibitors like selegiline and rasagiline help to prevent the breakdown of dopamine. Additionally, investigational drugs like PF-06649751, a D1/D5 dopamine receptor partial agonist, are being studied for their potential benefits in managing motor symptoms associated with Parkinson's Disease.

What other types of research exist?

Promising novel alternatives to RO7486967 for Parkinson's Disease patients in 2024 include: 1) PF-06649751, an oral, non-catechol-based, D1/D5 dopamine receptor partial agonist, which has shown efficacy in early-stage PD. 2) ONO-2160, a levodopa pro-drug combined with carbidopa, designed to stabilize levodopa plasma concentration fluctuations. Both agents are in advanced stages of clinical trials and have demonstrated potential in improving motor symptoms associated with PD.

← Back to Search

Other

RO7486967 for Early Parkinson's Disease

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new drug, RO7486967, in early-stage Parkinson's Disease patients to see if it is safe and how it works in the body. It includes patients who are either new to treatment or on stable medication.

Who is the study for?

This trial is for early-stage Parkinson's Disease patients, within 5 years of diagnosis and at a disease stage ≤2.5. Participants can be treatment-naïve or on stable PD therapy. They must have completed COVID-19 vaccination, have specific genotypes related to TSPO, and not expect changes in their PD therapy during the study.

What is being tested?

The trial tests RO7486967 against a placebo in people with early idiopathic Parkinson's Disease. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo until after results are collected.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the injection site, flu-like symptoms, headache, dizziness or gastrointestinal issues due to its pharmacological action.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RO7486967 ArmExperimental Treatment1 Intervention

Participants will receive RO07486967 for approximately 28 days with 14 days of follow up after the last dose.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RO7486967

2022

Completed Phase 1

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) work by addressing the dopaminergic deficit characteristic of the condition. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, directly replenishing the diminished neurotransmitter. Dopamine agonists (e.g., pramipexole, ropinirole) mimic dopamine by stimulating dopamine receptors. MAO-B inhibitors (e.g., rasagiline, selegiline) prevent the breakdown of brain dopamine, prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects. These mechanisms are crucial as they help alleviate motor symptoms, improving the quality of life for PD patients by enhancing mobility and reducing tremors and rigidity.

Pharmacologic approaches to the treatment of Huntington's disease.Initial agonist treatment of Parkinson disease: a critique.