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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dyskinesias, Parkinson Disease

Intervention / Treatment
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* Drug: Part 1, JM-010 component Group A
* Drug: Part 1, JM-010 component Group B
* Drug: Part 1, JM-010 component Group C
* Drug: Part 1, Placebo Group
* Drug: Part 2, JM-010 combination Group A
* Drug: Part 2, JM-010 combination Group B
* Drug: Part 2, JM-010 component Group C
* Drug: Part 2, Placebo Group


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1, JM-010 component Group A<br>Part 1, JM-010 component Group A | Drug: Part 1, JM-010 component Group A<br>* JM-010 component Group A<br>|
| Experimental: Part 1, JM-010 component Group B<br>Part 1, JM-010 component Group B | Drug: Part 1, JM-010 component Group B<br>* JM-010 component Group B<br>|
| Experimental: Part 1, JM-010 component Group C<br>Part 1, JM-010 component Group C | Drug: Part 1, JM-010 component Group C<br>* JM-010 component Group C<br>|
| Placebo Comparator: Part 1, Placebo Group<br>Part 1, Placebo Group | Drug: Part 1, Placebo Group<br>* Placebo Group<br>|
| Experimental: Part 2, JM-010 combination Group A<br>Part 2, JM-010 combination Group A | Drug: Part 2, JM-010 combination Group A<br>* JM-010 combination Group A<br>|
| Experimental: Part 2, JM-010 combination Group B<br>Part 2, JM-010 combination Group B | Drug: Part 2, JM-010 combination Group B<br>* JM-010 combination Group B<br>|
| Experimental: Part 2, JM-010 component Group C<br>Part 2, JM-010 component Group C | Drug: Part 2, JM-010 component Group C<br>* JM-010 component Group C<br>|
| Placebo Comparator: Part 2, Placebo Group<br>Part 2, Placebo Group | Drug: Part 2, Placebo Group<br>* Placebo Group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Dyskinesia Rating Scale (UDysRS) | Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 12 |