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Tavapadon for Parkinson's Disease (TEMPO-1 Trial)
TEMPO-1 Trial Summary
This trial is testing a new drug for early Parkinson's disease to see if it is safe and effective.
TEMPO-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEMPO-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEMPO-1 Trial Design
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Who is running the clinical trial?
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- Group 1: Placebo
- Group 2: Tavapadon 5 mg
- Group 3: Tavapadon 15 mg
Frequently Asked Questions
What is the FDA's position on Tavapadon?
"The safety of Tavapadon is estimated to be a 3. This assessment comes from Power, and it's based on the fact that this is a Phase 3 trial. That means there's some evidence that the drug works, as well as multiple rounds of data supporting its safety."
Does this research include elderly people as test subjects?
"28 clinical trials are available for patients under 18 years of age, 518 are available for those over 65, while this trial is recruiting adults aged 40-80."
Has there been any prior research on this topic?
"Tavapadon is being studied in 4 active clinical trials across 85 urban areas and 14 nations. The first ever trial for Tavapadon was completed in 2019. That year, the study- which was funded by Cerevel Therapeutics, LLC- included 522 patients and finished its Phase 3 drug approval process. Since then, a total of 18294 studies have been wrapped up."
Are people with the required qualifications able to participate in this trial right now?
"The trial is listed as currently seeking patients on clinicaltrials.gov, with the first posting date being December 13th, 2019 and the most recent update on September 7th, 2022."
Does Tavapadon have a long history of research?
"Tavapadon is currently being investigated in 4 clinical trials, with the majority of those research projects at Phase 3. Although most of the Tavapadon trials are based out of Philadelphia, Pennsylvania, there are a total 380 locations running these studies."
If I take part in this research, what are the guidelines I need to follow?
"This study is looking for 522 participants who are between the ages of 40 and 80 and have been diagnosed with Parkinson's disease. In addition to meeting this age and diagnosis criteria, potential participants must also: - Be sexually active men or women of childbearing potential that agree to use effective birth control methods or abstain from sexual activity during the trial and for 4 weeks after the last dose of trial treatment- Have a disease duration (from time of diagnosis) of less than 3 years and evidence of disease progression in the 3 years before signing informed consent- Be able to give signed informed consent which includes compliance with requirements"
How many people have been cleared to enroll in this clinical trial?
"A total of 522 patients are needed to enroll in this trial, with specific inclusion criteria. This study is being conducted at multiple sites including Houston, Texas and Ottawa, Ontario."
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