[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

+1-877-825-3327

Email address

medinfoUS@takeda.com

Condition

Healthy Participants,Parkinson Disease,Parkinson's Disease

Treatment type

Interventional

Investigational product

Placebo

Phase

Phase 2

Sponsor

Takeda

ClinicalTrials.gov identifier

NCT04334317

Study number

TAK-071-2002

Understanding clinical trials

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About the study

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 check for side effects. 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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. MDS) clinical diagnostic criteria for PD. Participants with DLB (ie, dementia diagnosed before onset of motor symptoms or up to 1 year after onset of motor
  2. symptoms) are also eligible, consistent with MDS clinical diagnostic criteria for PD. 3. Has Hoehn and Yahr stage >=2 and <4 at the screening visit. 4. Has elevated risk for falls as indicated by at least 2 falls in the last 6 months before the screening visit based on the Fall History Assessment where in the opinion of the investigator the falls were a consequence of PD. 5. Has evidence of cognitive impairment as indicated by a Montreal Cognitive Assessment (
  3. MoCA) score between 18 and 24, inclusive. 6. Can walk without aid for 2 minutes while doing serial 3 subtraction (with site staff ensuring participant safety in case of falls). Participants who require aids for walking can be included as long as they can complete the walk test without aid. Inclusion For Healthy Participants: 1. The participant is a healthy individual of either sex aged between 56 and 75 years, inclusive (for initial set of participant in the sentinel
  4. cohort) at the time of consent. Older participants may be enrolled after analysis of data from participants aged 56 to 75 years, inclusive. NOTE: Other protocol defined Inclusion/
Exclusion criteria
  1. SSRS) (based on the past
  2. year) before randomization are excluded. 5. 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: 1. Participants has body mass index (
  3. BMI) less than 18 or greater than 40. 2. 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). 3. 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. 4. The participant is taking warfarin. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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