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Study on the Long-Term Safety of Tavapadon for Patients with Parkinson's Disease

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Parkinson's disease, a condition that affects movement and can cause symptoms like tremors, stiffness, and difficulty with balance and coordination. The trial is testing a medication called Tavapadon, which is taken as a tablet. Tavapadon is an investigational drug, meaning it is still being studied and is not yet approved for general use. The purpose of this study is to evaluate the long-term safety and tolerability of Tavapadon for people diagnosed with Parkinson's disease.

Participants in the trial will take Tavapadon orally, which means by mouth, for a period of up to 58 weeks. During this time, researchers will monitor participants to see how they respond to the medication and to check for any side effects. The study will also look at how Tavapadon affects the symptoms of Parkinson's disease over the long term. This includes observing changes in movement and daily activities, as well as any adjustments in the use of other medications like L-Dopa, which is commonly used to manage Parkinson's symptoms.

The trial will involve regular check-ups, including physical and neurological examinations, to ensure participants' safety and to gather data on the effects of Tavapadon. Researchers will also collect information through various assessments and tests to understand how the medication impacts speech and facial expressions, which can be affected by Parkinson's disease. The study aims to provide valuable insights into the potential benefits and risks of using Tavapadon for managing Parkinson's disease over an extended period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon completion of a previous 27-week double-blind treatment period in a related trial, entry into this trial must occur within 72 hours.

    Participants must continue using levodopa/carbidopa or levodopa/benserazide if applicable.

  2. Step 2

    Medication administration

    The investigational product, tavapadon, is administered in tablet form.

    The route of administration is oral use.

  3. Step 3

    Trial duration

    The trial is designed to last for 58 weeks.

    The primary objective is to evaluate the safety and tolerability of long-term administration of tavapadon.

  4. Step 4

    Safety and tolerability assessments

    Regular assessments will be conducted to monitor the nature, frequency, and timing of any adverse effects.

    Evaluations include clinical laboratory tests, vital signs, physical and neurological examinations, and ECGs.

  5. Step 5

    Symptom evaluation

    The effects of tavapadon on Parkinson's disease symptoms will be assessed through changes in specific scores and diaries.

    Speech and facial expression characteristics may be analyzed using digital testing on a mobile device.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by December 12, 2025.

    Participants will be monitored for any changes in medication usage and overall health status.

Who can join the trial?

6 criteria

  • Participants must have completed a previous 27-week treatment period in one of the specified trials and join this new trial within 72 hours after their last visit in the previous trial. If they are from a specific trial, they must continue using certain medications for Parkinson's disease during the trial.
  • Men and women who can have children must agree to use effective birth control methods or choose not to have sexual activity during the trial and for 4 weeks after the last dose of the trial treatment.
  • Participants must be able to give their signed consent, which means they agree to follow the rules and requirements of the trial.
  • Participants must be able to understand the trial and follow the trial's rules, including taking the right doses of medication, attending scheduled visits, and completing tests and other trial activities.
  • Participants must have shown they could follow the trial's rules and take the trial medication properly in the previous trial.
  • Participants must agree not to take any Parkinson's disease medications that are not allowed by the trial rules during their participation in the trial.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Parkinson's disease cannot participate.
  • Individuals who are not within the specified age range for the study are excluded.
  • Participants who do not meet the gender requirements for the study are not eligible.
  • People who are considered part of a vulnerable population are excluded. This means individuals who might be at a higher risk of harm or exploitation.
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Investigated drugs

Tavapadon is a medication being studied for its potential use in treating Parkinson's Disease. The trial aims to assess how safe and well-tolerated this medication is when taken over a long period. Tavapadon works by targeting specific receptors in the brain that are involved in movement control, which may help alleviate symptoms of Parkinson's Disease.

What is already known about the treatment

Tavapadon – Tavapadon is administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating Parkinson's disease. The main therapeutic indication for Tavapadon is to manage symptoms associated with Parkinson's disease. At the molecular level, Tavapadon works by selectively stimulating dopamine receptors in the brain, which helps improve motor function. It is classified pharmacologically as a dopamine receptor agonist.

Investigated diseases

Parkinson's disease – Parkinson's disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and changes in speech and writing. The symptoms are due to the loss of dopamine-producing neurons in the brain. Over time, non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment may also develop. The progression of symptoms varies from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512123-37-00Protocol codeCVL-751-PD-004Estimated enrolment1 003 patientsSponsorCerevel Therapeutics LLC

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