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TAK-071 for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1: pre-dose and day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Awards & highlights

Study Summary

This trial is testing a new drug, TAK-071, to see if it helps people with Parkinson's disease to walk with better balance. The study will compare how participants walk after treatment with TAK-071 to how they walk after taking a placebo, and will also check if it improves participants' thinking and memory.

Eligible Conditions
  • Parkinson's Disease
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1: pre-dose and day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: pre-dose and day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Gait Variability during a 2-minute Dual-Task Walking Test After 6-week Treatment with TAK-071 Compared with Placebo
Sentinel Cohort, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants
Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants
+3 more
Secondary outcome measures
AUC(0-24): Area Under the Plasma Concentration-time Curve for TAK-071 in PD Participants
Change from Baseline in Global Cognition Profile
Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: TAK-071 + Placebo (PD Participants)Experimental Treatment2 Interventions
TAK-071 tablets, orally, once daily for up to first 6 weeks in Period 1, followed by ≥3 weeks washout period, followed by TAK-071 placebo-matching tablets, orally, once daily for up to next 6 weeks in Period 2.
Group II: Sentinel Cohort: TAK-071 7.5 mg (Healthy Participants)Experimental Treatment1 Intervention
A single dose of TAK-071 ≤ 7.5 milligrams (mg), tablet, orally, on Day 1.
Group III: Sentinel Cohort: Placebo (Healthy Participants)Experimental Treatment1 Intervention
A single dose of TAK-071 placebo-matching mg, tablet, orally, on Day 1.
Group IV: Placebo + TAK-071 (PD Participants)Experimental Treatment2 Interventions
TAK-071 placebo-matching tablets, orally, once daily for up to first 6 weeks in Period 1, followed by ≥3 weeks washout period, followed by TAK-071 tablets, orally, once daily for up to next 6 weeks in Period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
TAK-071
2020
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,198 Total Patients Enrolled
Michael J. Fox Foundation for Parkinson's ResearchOTHER
112 Previous Clinical Trials
535,092 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
63,183 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks might be associated with taking TAK-071?

"Our assessment of TAK-071's safety was determined to be a 2, as it has only been tested in Phase 2 trials and there is some preliminary data supporting its security but no efficacy data."

Answered by AI

Who is eligible to take part in this research?

"This medical experiment is seeking 64 individuals with Parkinson's disease who are aged between 40 and 85 years old. Essential requirements include: conforming to the Movement Disorders Society clinical diagnostic criteria for PD, at least one fall within the previous 12 months (as determined by a Fall History Assessment), an MoCA score of 11-26, capacity to walk without assistance for two minutes while doing serial 3 subtraction, being an outpatient, or aged 56–75 in case of the initial set of participants."

Answered by AI

How many sites are involved in the execution of this experiment?

"Suncoast Neuroscience Associates Inc in Saint Petersburg, Florida, University of Pennsylvania in Philadelphia, Pennsylvania and Quest Research institute in Farmington Hills Michigan are a few locations amongst the 25 that are recruiting patients for this trial."

Answered by AI

Is registration still open for this clinical research?

"As of now, this study does not require any more participants. It was initially posted on October 21st 2020 and last updated November 30th 2022. However, there are 1,320 other clinical trials actively recruiting patients currently."

Answered by AI

Are individuals over 30 years of age being accepted as participants in this investigation?

"Only those between the ages of 40 and 85 are eligible to join this clinical trial. Additionally, 77 trials have been conducted for patients below 18 years old while 849 have catered to individuals above 65."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Texas
How old are they?
18 - 65
What site did they apply to?
Evergreen Hospital Medical Center
Rocky Mountain Movement Disorders Center
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

N/a I am healthy. I try to help people by doing medical studies.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Baylor College of Medicine: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-071 in People With Parkinson Disease
2020. "A Study of TAK-071 in People With Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04334317.
~14 spots leftby Apr 2025
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