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Completed Phase 2 Interventional Results available

A Study of TAK-071 in People With Parkinson Disease

ClinicalTrials.gov ID: NCT04334317

Public ClinicalTrials.gov record NCT04334317. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 12:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04334317
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Takeda
Industry
Enrollment
64 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 20, 2020
Primary completion
Feb 26, 2023
Completion
Feb 26, 2023
Last update posted
May 13, 2024

2020 – 2023

United States locations

U.S. sites
21
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
Collaborative Neuroscience Network, LLC Garden Grove California 92845
University of California Irvine Medical Center Irvine California 92697
Cedars Sinai Medical Center Los Angeles California 90048
Rocky Mountain Movement Disorders Center Englewood Colorado 80113
PPD Phase 1 Clinic Orlando Florida 32806
Infinity Clinical Research, LLC Sunrise Florida 33351
USF Medical Clinic Tampa Florida 33612
Augusta University Augusta Georgia 30912
Feinberg School of Medicine Northwestern University Chicago Illinois 60611
Indiana University Health Neuroscience Center Indianapolis Indiana 46202
Quest Research Institute - Hunt - PPDS Farmington Hills Michigan 48334
Park Nicollet Health Services Golden Valley Minnesota 55427
University of Rochester Medicine - Movement Disorders Unit Rochester New York 14618
Neurology Diagnostics, Inc. - ERG - PPDS Dayton Ohio 45459
University of Philadelphia Philadelphia Pennsylvania 19107
Medical University of South Carolina - PPDS Charleston South Carolina 29425
Baylor College of Medicine Houston Texas 77030
Central Texas Neurology Round Rock Texas 78681
Meridian Clinical Research Norfolk Virginia 23502
Evergreen Hospital Medical Center Kirkland Washington 98034
Inland Northwest Research Spokane Washington 99202-6290

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04334317, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2024 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04334317 live on ClinicalTrials.gov.

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