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

NCT04377945 | Terminated Phase 2 FDA Drug

• 1 other identifier: BK-JM-201
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dyskinesias; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Unified Dyskinesia Rating Scale (UDysRS)

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

  Week 12

Secondary Outcomes (1)

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

  Week 12

Study Arms (8)

Part 1, JM-010 component Group A

EXPERIMENTAL

Part 1, JM-010 component Group A

Drug: Part 1, JM-010 component Group A

Part 1, JM-010 component Group B

EXPERIMENTAL

Part 1, JM-010 component Group B

Drug: Part 1, JM-010 component Group B

Part 1, JM-010 component Group C

EXPERIMENTAL

Part 1, JM-010 component Group C

Drug: Part 1, JM-010 component Group C

Part 1, Placebo Group

PLACEBO COMPARATOR

Part 1, Placebo Group

Drug: Part 1, Placebo Group

Part 2, JM-010 combination Group A

EXPERIMENTAL

Part 2, JM-010 combination Group A

Drug: Part 2, JM-010 combination Group A

Part 2, JM-010 combination Group B

EXPERIMENTAL

Part 2, JM-010 combination Group B

Drug: Part 2, JM-010 combination Group B

Part 2, JM-010 component Group C

EXPERIMENTAL

Part 2, JM-010 component Group C

Drug: Part 2, JM-010 component Group C

Part 2, Placebo Group

PLACEBO COMPARATOR

Part 2, Placebo Group

Drug: Part 2, Placebo Group

Interventions

Part 1, JM-010 component Group A DRUG

JM-010 component Group A

Part 1, JM-010 component Group A

Part 1, JM-010 component Group B DRUG

JM-010 component Group B

Part 1, JM-010 component Group B

Part 1, JM-010 component Group C DRUG

JM-010 component Group C

Part 1, JM-010 component Group C

Part 1, Placebo Group DRUG

Placebo Group

Part 1, Placebo Group

Part 2, JM-010 combination Group A DRUG

JM-010 combination Group A

Part 2, JM-010 combination Group A

Part 2, JM-010 combination Group B DRUG

JM-010 combination Group B

Part 2, JM-010 combination Group B

Part 2, JM-010 component Group C DRUG

JM-010 component Group C

Part 2, JM-010 component Group C

Part 2, Placebo Group DRUG

Placebo Group

Part 2, Placebo Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (2)

Bukwang Investigator site

Miami, Florida, 33165, United States

Location

Bukwang Investigator site

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Dyskinesias; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Sooyeon Park

  Bukwang Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: April 28, 2021
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)