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Tavapadon for Parkinson's Disease (TEMPO-4 Trial)
TEMPO-4 Trial Summary
This trial will look at the safety and effectiveness of a drug called tavapadon for people with Parkinson's Disease.
TEMPO-4 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEMPO-4 Trial Design
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Who is running the clinical trial?
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- I am joining this trial within 3 days of finishing my last trial.The doctor thinks you may be at risk of hurting yourself.You were previously in this trial and then decided to leave.You have had recent thoughts or actions related to wanting to harm yourself.I am using or will use effective birth control or remain abstinent during and 4 weeks after the trial.
- Group 1: Tavapadon
- 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.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Will this be the first time that this type of clinical trial has been performed?
"Research for Tavapadon began in 2019 with a clinical trial sponsored by Cerevel Therapeutics, LLC. A second study was conducted that same year which resulted in Tavapadon's approval as a Phase 3 drug. Currently, there are 4 active studies being conducted in 85 cities and 14 countries."
How many trial subjects are involved in this research?
"Unfortunately, this particular trial is no longer recruiting patients. It was originally posted on February 24th, 2021 and had its last update September 7th, 2022. If you are still seeking trials to participate in, there are 515 other studies for Parkinson's disease and 4 for Tavapadon currently looking for participants."
To what extent does this study's population reflect a cross-section of society?
"This clinical trial is open to 531 people with parkinson disease, aged 40-80. In order to be eligible, patients must meet the following criteria: They must have completed a previous 27 week double-blind treatment period from one of three trials, and enter this trial within 72 hours of their last visit from that study. Additionally, participants must agree to use birth control throughout the duration of the trial if they are sexually active, and refrain from taking any medication not permitted by the protocol. Lastly, investigators must judge the participant as being compliant with IMP requirements and willing to follow all restrictions laid out in the ICF and protocol."
Are adults above the age of 25 able to participate in this clinical trial?
"Eligibility requirements for this study show that patients must be between 40-80 years old. In contrast, there are 29 trials specifically for children and 516 studies searching for elderly participants."
Are there other cases in which Tavapadon has been tested in a controlled setting?
"Tavapadon was first studied in 2019 at Springub. Since then, there have been a total of six completed studies. There are four active clinical trials underway as of now; many of these are being conducted in Phoenix, Arizona."
Are there any adverse effects associated with Tavapadon use?
"Tavapadon's safety is estimated to be a 3 by our team at Power. This is due to the fact that Tavapadon is currently in Phase 3 clinical trials, meaning there have been multiple rounds of data supporting its efficacy and safety."
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