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NCT04223193 · ClinicalTrials.gov registry record · Phase 3
Flexible-Dose Trial in Early Parkinson's Disease (PD)
A Phase 3 study of Parkinson Disease, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT04223193: Completed Phase 3 study of Parkinson Disease, sponsored by AbbVie.
NCT04223193 is a Phase 3 study of Parkinson Disease that has completed, run by AbbVie. The registered enrollment target is 304 participants, below the 5,325-participant average among 297 other Parkinson Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04223193, a Phase 3 study of Parkinson Disease, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
Primary Outcome
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts: Part 1: Non-motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 2: Motor aspects of experiences of daily living (13 items. Score range: 0-52); Part 3: Motor examination (18 items. Score range: 0-132); Part 4: Motor complications (6 items. Score range: 0-24. Pa
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tavapadon
Study Locations (20)
Florida
- Boca Raton, Florida - Boca Raton
- Maitland, Florida - Maitland
- Ocala, Florida - Ocala
- Winter Park, Florida - Winter Park
Texas
- Cypress, Texas - Cypress
- Houston, Texas - Houston
- Lubbock, Texas - Lubbock
- Round Rock, Texas - Round Rock
New York
- Albany, New York - Albany
- Syracuse, New York - Syracuse
Ohio
- Cincinnati, Ohio - Cincinnati
- Cleveland, Ohio - Cleveland
Virginia
- Richmond, Virginia - Richmond
- Richmond, Virginia - Richmond
California
- Fresno, California - Fresno
Massachusetts
- Boston Neuro Research Center - North Dartmouth
Tennessee
- Memphis, Tennessee - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2020-01-06 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 3 |
What the finished NCT04223193 record still lists
NCT04223193 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 5,325-participant average among 297 other Parkinson Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04223193 names 20 study sites across 11 states, led by Florida, Texas, New York.
Frequently Asked Questions
What is clinical trial NCT04223193 about?
NCT04223193 is a clinical study titled "Flexible-Dose Trial in Early Parkinson's Disease (PD)". The purpose of this study is to assess the efficacy, safety, tolerability and pharmacokinetics (PK) of flexible doses of tavapadon in participants with Parkinson's Disease.
What is the current status of trial NCT04223193?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2020-01-06. Estimated completion is 2024-10-01.
What conditions does trial NCT04223193 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT04223193?
The interventions under investigation include: Placebo (DRUG), Tavapadon (DRUG).
Who is sponsoring clinical trial NCT04223193?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04223193 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04223193's enrollment target sits among peer trials
304 35th of 297 higher than 263 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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