[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

82-2-828-8260

Email address

yoon.jung.choi@bukwang.co.kr

Condition

Dyskinesia, Drug-Induced

Treatment type

Interventional

Investigational product

Part 1, JM-010 component Group A

Phase

Phase 2

Sponsor

Bukwang Pharmaceutical

ClinicalTrials.gov identifier

NCT04377945

Study number

BK-JM-201

Understanding clinical trials

Get answers to your questions about clinical trials.

About the study

This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinsons' Disease.

Who can take part?

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

Inclusion criteria
  1. Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
  2. Is male or female, between 18 and 80 years of age at Screening Visit.
  3. Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa.
  4. Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit
  5. Has stable peak-effect dyskinesia
  6. Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary
  7. Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day
Exclusion criteria
  1. Has undergone surgery for the treatment of PD
  2. Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),
  3. Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
  4. Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study
  5. Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.
  6. Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit).
  7. Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia. Other criteria related to other medical conditions to be referred to the protocol.

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