CClinicalTrials.gg
TerminatedNCT04377945SHINEUpdated Jun 17, 2024

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

A Phase 2 interventional study of Part 1, JM-010 component Group A and Part 1, JM-010 component Group B in Dyskinesias and Parkinson Disease, sponsored by Bukwang Pharmaceutical. Terminated at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-17.

Sponsored by Bukwang Pharmaceutical · Phase 2, Interventional, and Treatment

Why this study was terminated
Business reasons
Phase
Phase 2
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Dyskinesias
  • Parkinson Disease
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
  • Is male or female, between 18 and 85 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

Exclusion Criteria:

  • Has undergone surgery for the treatment of PD
  • Has a current diagnosis of Substance Use
  • Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
  • Has current seizure disorders requiring treatment with anticonvulsants.

Other criteria related to other medical conditions to be referred to the protocol.

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Part 1, JM-010 component Group A

    Part 1, JM-010 component Group A

    Drug: Part 1, JM-010 component Group A

  • Experimental
    Part 1, JM-010 component Group B

    Part 1, JM-010 component Group B

    Drug: Part 1, JM-010 component Group B

  • Experimental
    Part 1, JM-010 component Group C

    Part 1, JM-010 component Group C

    Drug: Part 1, JM-010 component Group C

  • Placebo comparator
    Part 1, Placebo Group

    Part 1, Placebo Group

    Drug: Part 1, Placebo Group

  • Experimental
    Part 2, JM-010 combination Group A

    Part 2, JM-010 combination Group A

    Drug: Part 2, JM-010 combination Group A

  • Experimental
    Part 2, JM-010 combination Group B

    Part 2, JM-010 combination Group B

    Drug: Part 2, JM-010 combination Group B

  • Experimental
    Part 2, JM-010 component Group C

    Part 2, JM-010 component Group C

    Drug: Part 2, JM-010 component Group C

  • Placebo comparator
    Part 2, Placebo Group

    Part 2, Placebo Group

    Drug: Part 2, Placebo Group

Interventions

  • DrugPart 1, JM-010 component Group A

    JM-010 component Group A

  • DrugPart 1, JM-010 component Group B

    JM-010 component Group B

  • DrugPart 1, JM-010 component Group C

    JM-010 component Group C

  • DrugPart 1, Placebo Group

    Placebo Group

  • DrugPart 2, JM-010 combination Group A

    JM-010 combination Group A

  • DrugPart 2, JM-010 combination Group B

    JM-010 combination Group B

  • DrugPart 2, JM-010 component Group C

    JM-010 component Group C

  • DrugPart 2, Placebo Group

    Placebo Group

05

What researchers measure

Primary outcomes

  1. Unified Dyskinesia Rating Scale (UDysRS)

    Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia

    Time frame: Week 12

Secondary outcomes

  1. Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Movement Disorder Society Unified Parkinson's Disease Rating Scale (Part III Scoring range: 0-137), higher score indicates more severe motor impairment

    Time frame: Week 12

06

Study locations

2 sites
  • Bukwang Investigator site
    Miami, Florida 33165, United States
  • Bukwang Investigator site
    Detroit, Michigan 48201, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04377945
Lead sponsor
Bukwang Pharmaceutical
Responsible party
Sponsor
First posted
May 7, 2020
Start date
Apr 28, 2021
Primary completion
Feb 14, 2024
Completion
Feb 14, 2024
Last update
Jun 17, 2024

Study contacts

Sooyeon Park
study director · Bukwang Pharmaceutical

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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