DyskinesiasPhase 2SHINENCT04377945
Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual Components
A Phase 2 study testing Part 1, JM-010 component Group A, Part 1, JM-010 component Group B and Part 1, JM-010 component Group C in people with Dyskinesias and Parkinson Disease, run by Bukwang Pharmaceutical at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dyskinesias, Parkinson Disease
- What is being tested?
- Part 1, JM-010 component Group A, Part 1, JM-010 component Group B and Part 1, JM-010 component Group C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Apr 2021to 14 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bukwang Investigator site
Detroit, Michigan, 48201
Bukwang Investigator site
Miami, Florida, 33165
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components
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.
- Conditions
- Dyskinesias, Parkinson Disease
- Being tested
- 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
- Medical subject headings
- Dyskinesias, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1, JM-010 component Group ADrug
JM-010 component Group A
Part 1, JM-010 component Group BDrug
JM-010 component Group B
Part 1, JM-010 component Group CDrug
JM-010 component Group C
Part 1, Placebo GroupDrug
Placebo Group
Part 2, JM-010 combination Group ADrug
JM-010 combination Group A
Part 2, JM-010 combination Group BDrug
JM-010 combination Group B
Part 2, JM-010 component Group CDrug
JM-010 component Group C
Part 2, Placebo GroupDrug
Placebo Group
| Study group | Role | What they receive |
|---|---|---|
| Part 1, JM-010 component Group A | Experimental | Part 1, JM-010 component Group A Receives: Drug: Part 1, JM-010 component Group A |
| Part 1, JM-010 component Group B | Experimental | Part 1, JM-010 component Group B Receives: Drug: Part 1, JM-010 component Group B |
| Part 1, JM-010 component Group C | Experimental | Part 1, JM-010 component Group C Receives: Drug: Part 1, JM-010 component Group C |
| Part 1, Placebo Group | Placebo comparator | Part 1, Placebo Group Receives: Drug: Part 1, Placebo Group |
| Part 2, JM-010 combination Group A | Experimental | Part 2, JM-010 combination Group A Receives: Drug: Part 2, JM-010 combination Group A |
| Part 2, JM-010 combination Group B | Experimental | Part 2, JM-010 combination Group B Receives: Drug: Part 2, JM-010 combination Group B |
| Part 2, JM-010 component Group C | Experimental | Part 2, JM-010 component Group C Receives: Drug: Part 2, JM-010 component Group C |
| Part 2, Placebo Group | Placebo comparator | Part 2, Placebo Group Receives: Drug: Part 2, Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dyskinesia Rating Scale (UDysRS)
Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia
Measured: 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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start28 Apr 2021
- Primary completion14 Feb 2024
- Study completion14 Feb 2024
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyskinesiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sooyeon Park, Study director, Bukwang Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377945
- Sponsor's protocol ID
- BK-JM-201
- Acronym
- SHINE
- Status last verified
- Jun 2024
- First submitted
- 4 May 2020
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components
- ClinicalTrials.gov ID
- NCT04377945
- Acronym / sponsor ID
- SHINE / BK-JM-201
- Conditions
- Dyskinesias, Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1, JM-010 component Group A | Experimental | Drug: Part 1, JM-010 component Group APart 1, JM-010 component Group A |
| Part 1, JM-010 component Group B | Experimental | Drug: Part 1, JM-010 component Group BPart 1, JM-010 component Group B |
| Part 1, JM-010 component Group C | Experimental | Drug: Part 1, JM-010 component Group CPart 1, JM-010 component Group C |
| Part 1, Placebo Group | Placebo comparator | Drug: Part 1, Placebo GroupPart 1, Placebo Group |
| Part 2, JM-010 combination Group A | Experimental | Drug: Part 2, JM-010 combination Group APart 2, JM-010 combination Group A |
| Part 2, JM-010 combination Group B | Experimental | Drug: Part 2, JM-010 combination Group BPart 2, JM-010 combination Group B |
| Part 2, JM-010 component Group C | Experimental | Drug: Part 2, JM-010 component Group CPart 2, JM-010 component Group C |
| Part 2, Placebo Group | Placebo comparator | Drug: Part 2, Placebo GroupPart 2, Placebo Group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1, JM-010 component Group AJM-010 component Group A | Drug | Part 1, JM-010 component Group A |
| Part 1, JM-010 component Group BJM-010 component Group B | Drug | Part 1, JM-010 component Group B |
| Part 1, JM-010 component Group CJM-010 component Group C | Drug | Part 1, JM-010 component Group C |
| Part 1, Placebo GroupPlacebo Group | Drug | Part 1, Placebo Group |
| Part 2, JM-010 combination Group AJM-010 combination Group A | Drug | Part 2, JM-010 combination Group A |
| Part 2, JM-010 combination Group BJM-010 combination Group B | Drug | Part 2, JM-010 combination Group B |
| Part 2, JM-010 component Group CJM-010 component Group C | Drug | Part 2, JM-010 component Group C |
| Part 2, Placebo GroupPlacebo Group | Drug | Part 2, Placebo Group |
Primary outcome
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: Week 12
Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia
1 secondary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Week 12
Results and safety
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Dyskinesias
RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sooyeon Park study director
Bukwang Pharmaceutical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Part 1, JM-010 component Group A, Part 1, JM-010 component Group B and Part 1, JM-010 component Group C in people with Dyskinesias and Parkinson Disease, run by Bukwang Pharmaceutical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Dyskinesia Rating Scale (UDysRS) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.