What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa and dopamine agonists, often have side effects including nausea, dizziness, somnolence, and orthostatic hypotension. More serious side effects can include confusion, hallucinations, delusions, and psychosis, particularly in older patients. Cholinesterase inhibitors, used for cognitive impairment in PD, can cause nausea, vomiting, and worsened tremor. These side effects necessitate careful monitoring and dose adjustments by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, focusing primarily on dopaminergic therapies. These include Levodopa, often combined with Carbidopa, which remains the most effective treatment for motor symptoms. Dopamine agonists such as Pramipexole, Ropinirole, and Rotigotine are also approved and work by stimulating dopamine receptors. Monoamine oxidase B (MAO-B) inhibitors like Selegiline and Rasagiline help increase dopamine levels in the brain. While Tavapadon, a Dopamine D1/D5 Receptor Partial Agonist, is still under investigation, it represents a novel approach that could complement existing therapies by targeting specific dopamine receptors to manage motor fluctuations.

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 with fewer side effects. 2) Rasagiline, which offers a different mode of action and is a valuable alternative for patients with motor fluctuations. 3) Perampanel, an AMPA-receptor antagonist, which has demonstrated efficacy in reducing motor symptoms in PD patients.

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Dopamine Agonist

Tavapadon for Parkinson's Disease (TEMPO-3 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

Participants with modified Hoehn and Yahr stage 2, 2.5, or 3 in the "on" state.

Participants who are on a stable dose of L-Dopa for at least 4 weeks prior to screening and are taking a minimum total daily dose of 400 milligram (mg) divided in at least 4 doses per day of standard carbidopa/levodopa or divided in at least 3 doses per day of extended-release carbidopa/levodopa capsules. The carbidopa/levodopa dose and frequency must be maintained for the duration of the trial.

Must not have

Participants with a history or clinical features consistent with essential tremor, atypical or secondary parkinsonian syndrome (including, but not limited to, progressive supranuclear palsy, multiple system atrophy, cortico-basal degeneration, or drug-induced or poststroke parkinsonism).

Participants with a history of nonresponse or insufficient response to L-Dopa at therapeutic dosages.

Timeline

Screening 31 days

Treatment 27 weeks

Follow Up 1 month

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called tavapadon. It aims to help people with Parkinson's Disease who are already taking L-Dopa and experiencing varying symptoms throughout the day. The goal is to increase the number of hours they have good control over their movements without troublesome involuntary movements.

Who is the study for?

Adults aged 40-80 with Parkinson's Disease who respond well to L-Dopa, are on a stable dose of it, and experience at least 2.5 hours of 'off' time daily. They must use birth control or abstain if they can have children. Exclusions include psychosis history within the last year, significant cognitive impairment, substance abuse in the past 6 months, certain medical conditions affecting drug absorption or causing severe health risks.

What is being tested?

The trial is testing Tavapadon as an additional treatment for Parkinson's alongside standard L-Dopa therapy versus a placebo. The main goal is to see if Tavapadon increases the daily 'on' time without troublesome dyskinesia (involuntary movements) compared to not taking it.

What are the potential side effects?

Tavapadon may cause side effects such as nausea, headache, dizziness, sleep disturbances or unusual dreams. It might also lead to involuntary movements (dyskinesia), which will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's disease is at a moderate stage.

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I've been on a stable dose of L-Dopa for Parkinson's, at least 400 mg daily, for over 4 weeks.

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I am between 40 and 80 years old.

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I have Parkinson's with slow movements and uneven symptoms on both sides.

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My Parkinson's disease is at a moderate stage.

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I have completed a diary showing I have at least 2.5 hours of 'off' time for 2 days.

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I've been on a stable dose of L-Dopa for Parkinson's, at least 400 mg daily, for over 4 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history or symptoms of essential tremor or other non-standard Parkinson-like conditions.

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My condition did not improve with L-Dopa treatment.

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I have or had a brain tumor, severe head injury, epilepsy, or seizures.

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I haven't had serious heart issues or uncontrolled heart rhythm problems in the last year.

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I am not taking any strong medication that affects liver enzymes.

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I have severe dizziness or fainting when standing up.

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My kidneys are not working well or I am on dialysis.

Timeline

Screening ~ 31 days1 visit

Treatment ~ 27 weeks9 visits

Follow Up ~ 1 month1 visit

Screening ~ 31 days

Treatment ~ 27 weeks

Follow Up ~1 month

This trial's timeline: 31 days for screening, 27 weeks for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change From Baseline in Total Daily "Off" Time Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)

Change From Baseline in Total Daily "Off" Time Without Troublesome Dyskinesia Based on the 2-Day Average of the Self-Completed Home Diary for Motor Function Status (Hauser Diary)

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III Individual Score

+1 more

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TavapadonExperimental Treatment1 Intervention

Participants will receive a tavapadon tablet titrated 5 to 15 milligrams (mg) once daily (QD) orally for 27 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo matching to tavapadon tablet QD orally for 27 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tavapadon

Not yet FDA approved

0 / 14Eligibility criteria met

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 stimulate dopamine receptors to improve motor function. Levodopa, a dopamine precursor, is converted to dopamine in the brain, providing significant symptomatic relief. MAO-B inhibitors prevent the breakdown of dopamine, extending its beneficial effects. Tavapadon, a dopamine D1/D5 receptor partial agonist, targets specific dopamine receptors to modulate motor activity, potentially offering a more targeted treatment with fewer side effects. These mechanisms are crucial for managing PD symptoms and improving patients' quality of life.

Dopamine agonists in Parkinson's disease.Pharmacologic approaches to the treatment of Huntington's disease.