A Study of TAK-071 in People With Parkinson Disease
Completed · Phase 2 · Has a placebo group
Conditions studied: Parkinson Disease, Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT04334317
- Run by
- Takeda
- People needed
- 64
- Starts
- 2020-10-21
- Expected to finish
- 2023-02-27
- Last updated by the study team
- 2024-05-14
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Collaborative Neuroscience Network, LLC — Garden Grove, California, United States
- University of California Irvine Medical Center — Irvine, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Rocky Mountain Movement Disorders Center — Englewood, Colorado, United States
- PPD Phase 1 Clinic — Orlando, Florida, United States
- Infinity Clinical Research, LLC — Sunrise, Florida, United States
- USF Medical Clinic — Tampa, Florida, United States
- Augusta University — Augusta, Georgia, United States
- Feinberg School of Medicine Northwestern University — Chicago, Illinois, United States
- Indiana University Health Neuroscience Center — Indianapolis, Indiana, United States
- Quest Research Institute - Hunt - PPDS — Farmington Hills, Michigan, United States
- Park Nicollet Health Services — Golden Valley, Minnesota, United States
- University of Rochester Medicine - Movement Disorders Unit — Rochester, New York, United States
- Neurology Diagnostics, Inc. - ERG - PPDS — Dayton, Ohio, United States
- University of Philadelphia — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina - PPDS — Charleston, South Carolina, United States
- Baylor College of Medicine — Houston, Texas, United States
- Central Texas Neurology — Round Rock, Texas, United States
- Meridian Clinical Research — Norfolk, Virginia, United States
- Evergreen Hospital Medical Center — Kirkland, Washington, United States
- Inland Northwest Research — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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