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NCT04334317 · ClinicalTrials.gov registry record · Phase 2
A Study of TAK-071 in People With Parkinson Disease
A Phase 2 study of Parkinson Disease and Healthy Participants, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 20
- Study locations
NCT04334317: Completed Phase 2 study of Parkinson Disease and Healthy Participants, sponsored by Takeda.
NCT04334317 is a Phase 2 study of Parkinson Disease and Healthy Participants that has completed, run by Takeda. The registered enrollment target is 64 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04334317, a Phase 2 study of Parkinson Disease and Healthy Participants, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 20
- Study locations
Study Summary
It is hoped that TAK-071 will help people with Parkinson's disease to walk with better balance. The main aim of the study is to check if there is a difference in how participants walk after treatment with TAK-071. Another aim is to see if it improves how participants think and remember. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 groups by chance. Both groups will have 2 treatments but in a different order. The treatments are TAK-071 tablets or placebo. In this study, a placebo will look like the TAK-071 but will not have any medicine in it. One group will take TAK-071 for 6 weeks, have at least a 3-week break, then take a placebo for 6 weeks. The other group will take a placebo for 6 weeks, have at least a 3-week break, then take TAK-071 for 6 weeks. The participants will not know the order of their 2 treatments, nor will their study doctors. This is to help make sure the results are more reliable. The participants will visit the clinic at the beginning and end of each treatment for a check-up. 14 days after the 2nd treatment, clinic staff will telephone the participants for a final check-up.
Primary Outcome
Stride time (or gait) is defined as the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in seconds. The standard deviation (SD) of the stride time, recorded for each foot during the 2-minutes, is averaged to obtain stride time (gait) variability. The 2-minute walk was performed with and without simultaneous performance of serial 3 subtraction, which adds a cognitive load to the task. Data are reported with and without cognitive load.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-071
Study Locations (20)
California
- Collaborative Neuroscience Network, LLC - Garden Grove
- University of California Irvine Medical Center - Irvine
- Cedars Sinai Medical Center - Los Angeles
Florida
- PPD Phase 1 Clinic - Orlando
- Infinity Clinical Research, LLC - Sunrise
- USF Medical Clinic - Tampa
Texas
- Baylor College of Medicine - Houston
- Central Texas Neurology - Round Rock
Colorado
- Rocky Mountain Movement Disorders Center - Englewood
Georgia
- Augusta University - Augusta
Illinois
- Feinberg School of Medicine Northwestern University - Chicago
Indiana
- Indiana University Health Neuroscience Center - Indianapolis
Michigan
- Quest Research Institute - Hunt - PPDS - Farmington Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2023-02-27 |
| Phase | Phase 2 |
What the finished NCT04334317 record still lists
NCT04334317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04334317 names 20 study sites across 15 states, led by California, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04334317 about?
NCT04334317 is a clinical study titled "A Study of TAK-071 in People With Parkinson Disease". It is hoped that TAK-071 will help people with Parkinson's disease to walk with better balance. The main aim of the study is to check if there is a difference in how participants walk after treatment with TAK-071. Another aim is to see if it improves how participants think and remember. At the firs...
What is the current status of trial NCT04334317?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2020-10-21. Estimated completion is 2023-02-27.
What conditions does trial NCT04334317 study?
This clinical trial studies the following conditions: Parkinson Disease, Healthy Participants.
What interventions are being tested in trial NCT04334317?
The interventions under investigation include: Placebo (DRUG), TAK-071 (DRUG).
Who is sponsoring clinical trial NCT04334317?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04334317 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04334317's enrollment target sits among peer trials
64 120th of 297 higher than 177 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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