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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 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.

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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.

Conditions Studied

Parkinson Disease Healthy Participants

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

FieldValue
Enrollment Target 64 participants
Start Date 2020-10-21
Est. Completion 2023-02-27
Phase Phase 2

Sponsor

Takeda

408 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04334317

The ClinicalTrials.gov registry entry for NCT04334317 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.