Phase 2
Completed N=64
A Study of TAK-071 in People With Parkinson Disease
Parkinson's Disease · Healthy Participants
Source: ClinicalTrials.gov NCT04334317 ↗
Enrolled (actual)
64
Serious AEs
2.7%
Results posted
May 2024
Primary outcomePrimary: Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With Placebo — 0.0546; 0.0625; 0.0930; 0.0861 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With Placebo |
0.0546; 0.0625; 0.0930; 0.0861; 0.0534; 0.0607 | — |
| PRIMARY Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy Participants |
186 | — |
| PRIMARY Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy Participants |
1.50 | — |
| PRIMARY Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy Participants |
3050 | — |
| PRIMARY Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy Participants |
11800 | — |
| PRIMARY Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy Participants |
14600 | — |
| SECONDARY Main Cohort: Change From Baseline in Global Cognition Z-score |
-0.059; 0.208 | — |
| SECONDARY Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) Participants |
339 | — |
| SECONDARY Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD Participants |
125 | — |
| SECONDARY Main Cohort: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-071 in PD Participants |
480 | — |
| SECONDARY Main Cohort: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in PD Participants |
2360 | — |
| SECONDARY Main Cohort, AUCtau: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-071 in PD Participants |
9360 | — |
| SECONDARY Main Cohort, Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-071 in PD Participants |
2.10 | — |
| SECONDARY Main Cohort: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in PD Participants |
1.75 | — |
Eligibility Criteria
Key Inclusion Criteria
- Is an outpatient of any sex aged between 40 and ≤ 85 years, inclusive, at the time of consent.
- Has a diagnosis of PD according to Movement Disorders Society (MDS) clinical diagnostic criteria for PD. Participants with DLB (i.e., dementia diagnosed before onset of motor symptoms or up to 1 year after onset of motor symptoms) are also eligible, consistent with MDS clinical diagnostic criteria for PD.
- Has Hoehn and Yahr stage ≥2 and ] 2), or in the opinion of the investigator the participant's dyskinesia is likely to interfere with the digital gait assessments.
- Has significant risk factors for seizures (a history of seizures as an adult, a history of brain injury, or other risk factors deemed relevant by the investigator).
- Is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening. Participants who have positive answers on item number 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) (based on the past year) before randomization are excluded.
- Is unwilling or unable to discontinue taking cholinesterase inhibitors and/or moderate or strong cytochrome P-450 3A4 inhibitors or inducers at least 30 days before randomization.
Exclusion For Healthy Participants:
- Participants has body mass index (BMI) less than 18 or greater than 40.
- Has significant risk factors for seizures (a history of seizures as an adult, a history of brain injury, or other risk factors deemed relevant by the investigator).
- The participant is unwilling or unable to discontinue taking cholinesterase inhibitors and/or moderate or strong CYP 3A4 inhibitors or inducers at least 30 days before randomization.
- The participant is taking warfarin.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04334317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.