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Tavapadon for Parkinson's Disease (TEMPO-2 Trial)
TEMPO-2 Trial Summary
This trial will evaluate a new drug for Parkinson's Disease to see if it is effective, safe, and well tolerated.
TEMPO-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTEMPO-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TEMPO-2 Trial Design
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Who is running the clinical trial?
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- I have a condition that might affect how my body absorbs medication.I have moderate to severe kidney problems.I agree to use effective birth control or remain abstinent during and 4 weeks after the trial.You are at risk of hurting yourself.I did not respond well to L-Dopa treatment at therapeutic doses.You have a history of a serious problem controlling your impulses.My condition has worsened in the last 3 years and it started less than 3 years ago.You have had a serious reaction to certain medications affecting the nervous system in the past.I have a history of brain tumor, severe head trauma, epilepsy, or seizures.I experience significant dizziness when standing up.I can sign the consent form and follow the study's requirements.I can stop taking certain Parkinson's disease medications if needed for the trial.I am currently taking medication that strongly affects liver enzymes.I have been diagnosed with or show signs of essential tremor or atypical parkinsonism.My Parkinson's disease is in the early stages.My Parkinson's symptoms affect my daily activities and movement significantly.I have early Parkinson's disease and need medication to manage it.I have either not been treated or only had short-term treatment with dopamine drugs.I have had heart issues like a heart attack or heart failure in the last year.You have experienced hallucinations or psychosis in the past year.You have had problems with using drugs or alcohol in the last 6 months.You have been diagnosed with Parkinson's disease according to specific criteria from the UK Parkinson's Disease Society Brain Bank.
- Group 1: Tavapadon
- Group 2: Placebo
- 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
Would I be able to qualify to participate in this research study?
"This is a study for people with Parkinson's disease aged from 40 to 80. The main requirements are as follows: The participant must be male or female, and aged 40 to 80 years old when they sign the informed consent form. They must be able to understand and sign the informed consent form. They must have a modified Hoehn and Yahr stage of 1, 1.5, or 2. They must have had the disease for less than 3 years, and the disease must have progressed in the 3 years before signing the informed consent form. They must have an MDS-UPDRS Part II score of 2 or more and"
Can adults of any age join this research project?
"This trial is for patients who are aged 40 to 80. There are currently 29 clinical trials underway for people younger than 18 and 509 for patients older than 65."
How many different hospitals are coordinating this trial?
"To make the process as convenient as possible for participants, the clinical trial is being conducted at 17 sites. These locations include Syracuse, Fresno, Coral Springs and 14 other cities."
Are there still spots open for people who want to participate in this experiment?
"That is correct, the online information does show that this study is recruiting patients. The trial was first announced on January 6th, 2020 and has since been updated on September 7th, 2020. They are looking for a total of 296 patients spread out over 17 different locations."
How many people are going to participate in this trial?
"That is correct. The clinical trial is ongoing, as denoted by the fact that it was posted on 1/6/2020 and updated as recently as 9/7/2022 on clinicaltrials.gov. They are looking for 296 participants who are willing to go to one of the 17 locations."
When might the FDA approve Tavapadon?
"Tavapadon ranks highly in terms of safety due to the amount of Phase 3 trial data supporting both its efficacy and safety."
Has Tavapadon been used in other medical research studies?
"Tavapadon was first studied in 2019 at the Padova medical research centre. As of now, there have been 18,249 completed studies. There are 4 active studies at the moment, with a few of them taking place in Syracuse, New york."
Does this research study break new ground?
"There are 4 ongoing clinical trials for the medication Tavapadon in 85 cities and 14 countries. The first trial was completed in 2019 by Cerevel Therapeutics, LLC. That particular study reached Phase 3 and had 522 participants. Since then, 18249 more trials have been run."
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