What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa and dopamine agonists, often cause side effects like nausea, somnolence, dizziness, headache, orthostatic hypotension, confusion, hallucinations, and dyskinesia. Cholinesterase inhibitors, used for cognitive impairment, can lead to worsened tremor, nausea, and vomiting. These side effects vary in severity and frequency, and careful monitoring and dose adjustments are typically required to manage them.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including levodopa, dopamine agonists, MAO-B inhibitors, and COMT inhibitors. Levodopa, often combined with carbidopa, remains the most effective treatment for motor symptoms. Dopamine agonists like pramipexole and ropinirole mimic dopamine effects in the brain. MAO-B inhibitors such as selegiline and rasagiline help prevent dopamine breakdown. COMT inhibitors like entacapone extend the effect of levodopa. While Tavapadon, a Dopamine D1/D5 receptor partial agonist, is still under investigation, it represents a novel approach potentially offering benefits similar to existing dopamine-based therapies but with a different mechanism of action.

What other types of research exist?

Promising novel alternatives to Tavapadon for Parkinson's Disease patients include: 1) S32504, a D3/D2 dopamine receptor agonist, which has shown advantages over L-dopa without significant dyskinesia. 2) Perampanel, an AMPA-receptor antagonist, which has demonstrated efficacy in reducing motor symptoms in PD patients. 3) Ropinirole, a selective D2 agonist, which has been effective as an adjunct to levodopa in managing motor fluctuations.

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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-4 Trial)

Phase 3

Waitlist Available

Research Sponsored by Cerevel Therapeutics, LLC

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 baseline (day 1), weeks 32 and 58

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called tavapadon to see if it is safe and effective for people with Parkinson's Disease. The medication aims to help manage symptoms like tremors and stiffness by targeting specific parts of the brain.

Who is the study for?

This trial is for people with Parkinson's Disease who were part of certain previous trials and can start this one within 72 hours after the last visit. They must use effective birth control or abstain, be able to follow the study rules, avoid unapproved PD medications, and have been compliant in past trials.

What is being tested?

The study tests long-term safety and effectiveness of varying doses of tavapadon in treating Parkinson's Disease. It's an open-label trial, meaning both researchers and participants know what treatment is being given.

What are the potential side effects?

While not specified here, common side effects for Parkinson’s treatments like tavapadon may include nausea, dizziness, insomnia, dry mouth or constipation. Each person might experience these differently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1), weeks 32 and 58

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1), weeks 32 and 58

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), weeks 32 and 58 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index

Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)

Change From Baseline in the Hauser diary

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TavapadonExperimental Treatment1 Intervention

Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tavapadon

Not yet FDA approved

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

Common treatments for Parkinson's Disease (PD) primarily focus on dopaminergic therapies due to the loss of dopamine-producing neurons in PD. Dopamine agonists like pramipexole, ropinirole, and rotigotine directly stimulate dopamine receptors, improving motor symptoms. Levodopa, a precursor to dopamine, is converted to dopamine in the brain, providing significant symptomatic relief. MAO-B inhibitors extend the action of dopamine by preventing its breakdown. Tavapadon, a dopamine D1/D5 receptor partial agonist, is being studied for its potential to selectively stimulate specific dopamine receptors, which may offer effective symptom control with fewer side effects. These treatments are essential for managing PD symptoms and enhancing patients' quality of life.

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