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Dopamine Agonist

Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg for Parkinson's Disease

Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 36
Awards & highlights

Study Summary

This trial tests if a 15mg Tavapadon tablet is equivalent to taking 3x5mg tablets for Parkinson's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUCτ) of Tavapadon
Maximum Observed Plasma Concentration (Cmax) of Tavapadon
Secondary outcome measures
Plasma Exchange
Average Steady-state Plasma Concentration (Cavg,ss) of Tavapadon
Feeling suicidal (finding)
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mgExperimental Treatment1 Intervention
Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 15 to 21. Participants will receive tavapadon 1x15 mg tablet, orally, QD from Day 22 to 28.
Group II: Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mgExperimental Treatment1 Intervention
Participants will receive tavapadon 1x15 mg tablet, orally, once daily (QD) from Day 15 to 21. Participants will receive tavapadon 3x5 mg tablets, orally, QD from Day 22 to 28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tavapadon
2022
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
34 Previous Clinical Trials
5,670 Total Patients Enrolled

Media Library

Tavapadon (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05610189 — Phase 1
Parkinson's Disease Research Study Groups: Cohort 1: Tavapadon 1x15 mg Followed by 3x5 mg, Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg
Parkinson's Disease Clinical Trial 2023: Tavapadon Highlights & Side Effects. Trial Name: NCT05610189 — Phase 1
Tavapadon (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610189 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accept volunteers of senior age?

"The study is seeking participants aged 45 or older and below the age of 80."

Answered by AI

How many participants are there in this clinical investigation?

"Affirmative. According to records on clinicaltrials.gov, this medical experiment is seeking participants and was initially published in mid-December of 2022 before being revised a few days later. The goal is to recruit 24 people at 1 site for the trial."

Answered by AI

How risk-free is Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg for patients?

"Considering the limited data available for Cohort 2: Tavapadon 3x5 mg Followed by 1x15 mg, it received a score of 1 in terms of safety. This is expected as this trial is at its initial phase and has yet to generate sufficient evidence regarding efficacy and security."

Answered by AI

Are there any slots remaining for prospective participants in this investigation?

"Affirmative. According to information recorded on clinicaltrials.gov, this research is still looking for subjects to take part in it. Established on December 15th 2022, the trial's most recent update was made four days later and they are recruiting 24 individuals from a single location."

Answered by AI

Who is eligible to join this research experiment?

"This clinical trial is recruiting 24 participants aged between 45 and 80 who have been diagnosed with Parkinson's disease. It is essential that these patients fulfill the following criteria: BMI from 17.5 to 38 kg/m^2, total body weight over 50kg (110lb) at screening, diagnosis in line with UK Brain Bank guidelines for PD, minimum L-Dopa dose of 300mg daily administered three times a day for two weeks prior to Day 1 Visit."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
South Miami, Florida
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Apr 2025