[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

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site

Study’s contact

Call center

+1-877-825-3327

Email address

medicalinformation@tpna.com

Condition

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

Get answers to your questions about clinical trials.

About the study

The purpose of this study is to evaluate the effect of TAK-071 when compared to placebo on gait in patients with Parkinson Disease (PD) who also have cognitive impairment. Safety and tolerability of TAK-071 will also be established in participants with Parkinson Disease.

Who can take part?

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

Inclusion criteria
  1. PD) according to Movement Disorders Society (
  2. MDS) clinical diagnostic criteria for PD. 2. Has Modified Hoehn and Yahr stage ≥2.0 and <4.0 at the screening visit. 3. 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. 4. Has evidence of cognitive impairment as indicated by a Montreal Cognitive Assessment (
  3. MoCA) score between 18 and 24, inclusive. NOTE: Other protocol defined Inclusion/
Exclusion criteria
  1. UPDRS) section 4.1 "Time spent with dyskinesias" and/or section 4.2 "Functional Impact of Dyskinesias" scores >2). 3. Has significant risk factors for seizures (eg, a history of seizures as an adult, or a history of brain injury). 4. The participant 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. participant who have positive answers on item number 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-
  2. SSRS) (based on the past
  3. year) before randomization are excluded. 5. Has taken a cholinesterase inhibitor and/or a moderate or strong cytochrome P-450 3A4 inhibitor or inducer within 30 days of screening and is unable to discontinue these drugs at least 30 days before the baseline visit. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site