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A Study of TAK-071 in People With Parkinson Disease

Research Question:
The primary objectives of this study for people with Parkinson's disease are 1) to evaluate the efficacy of TAK-071 versus placebo on gait dysfunction, as measured by gait variability during a 2-minute walk test, and 2) to evaluate the safety and tolerability of TAK-071.

Basic Study Information

Purpose:
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.

Location: University of Rochester Medicine - Movement Disorders Unit
Study Reference #: 5945

Lead Researcher (Principal Investigator)

Lead Researcher:  Karlo Lizarraga mendoza

Study Contact Information

Study Coordinator: Amy Chesire (Clinical Research Manager)
Phone: (585) 341-7500
Email: Amy_Chesire@URMC.Rochester.edu

Additional Study Details

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