Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components (SHINE)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    188
  • sponsor
    Bukwang Pharmaceutical
Updated on 25 April 2022
levodopa
dyskinesia
parkinson's disease

Summary

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

Description

This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study.

Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.

For more information, please visit:

www.SHINEParkinsonsStudy.com

Details
Condition Dyskinesias, Parkinson Disease
Treatment Part 1, JM-010 component Group A, Part 1, JM-010 component Group B, Part 1, JM-010 component Group C, Part 1, Placebo Group, Part 2, JM-010 combination Group A, Part 2, JM-010 combination Group B, Part 2, Placebo Group, Part 2, JM-010 component Group C
Clinical Study IdentifierNCT04377945
SponsorBukwang Pharmaceutical
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Is able to read, understand, and provide written, dated informed consent prior to Screening Visit
Is male or female, between 18 and 80 years of age at Screening Visit
Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
Has experienced dyskinesia
Has stable peak-effect dyskinesia
Has more than one hour of "ON" time with troublesome dyskinesia

Exclusion Criteria

Has undergone surgery for the treatment of PD
Has a current diagnosis of Substance Use
Has current seizure disorders requiring treatment with anticonvulsants
Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
Other criteria related to other medical conditions to be referred to the
protocol
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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