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Dopamine Agonist

Tavapadon Followed by Tavapadon + Carbamazepine 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 36
Awards & highlights

Study Summary

This trial will look at how a drug affects the body when taken with another drug to see if it is safe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 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
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Number of Participants With Adverse Events (AEs) and AEs by Severity
Number of Participants with Clinically Significant Changes in Clinical Laboratory Assessments
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tavapadon Followed by Tavapadon + CarbamazepineExperimental Treatment2 Interventions
Participants will receive oral tavapadon tablets titrated up to a steady-state dose from Day 1 to Day 14. From Day 15, participants will receive oral carbamazepine tablets titrated up to a steady-state dose along with oral tavapadon tablets, up to Day 30.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tavapadon
2022
Completed Phase 1
~90
Carbamazepine
2016
Completed Phase 4
~2690

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
34 Previous Clinical Trials
5,679 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must be met for one to qualify for this clinical research?

"This trial is open to 16 people aged between 18 and 55 who have been diagnosed with Parkinson's disease. Furthermore, they must be nonchildbearing women or sexually active men of childbearing potential that agree to use condoms; their body mass index needs to fall within the range of 18.5-32 kg/m2 (with a total weight above 50kg) as well as demonstrate overall health through medical evaluation including physical examination, ECG etc.; finally participants need to understand the nature of this research and comply with all protocol requirements such as dosage regimens, follow up visits etc."

Answered by AI

Are there still vacancies for participants in this examination?

"Clinicaltrials.gov suggests that this clinical trial is still searching for participants, as the original post date was October 19th 2022 and it has been recently edited on November 3rd of the same year."

Answered by AI

Has the FDA sanctioned Tavapadon Followed by Tavapadon + Carbamazepine?

"There is limited evidence of tavapadon, in combination with carbamazepine's safety and efficacy; therefore, the assessment score was a 1."

Answered by AI

Is enrollment to this experiment open for octogenarian individuals?

"This trial has an age requirement of 18 to 55 years old. For those younger than the required age, there are 27 studies available and 482 for those exceeding the upper limit."

Answered by AI

How many individuals can potentially benefit from this trial?

"Affirmative. The information on clinicaltrials.gov suggests this medical trial is still recruiting patients, and was first posted on October 19th 2022. Subsequently, it was last modified November 3rd 2022 and requires 16 participants from one location to be enrolled."

Answered by AI
~6 spots leftby Apr 2025