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

Bukwang Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: Parkinson Disease; Dyskinesias

Treatments: Drug: Part 2, JM-010 component Group C; Drug: Part 1, JM-010 component Group B; Drug: Part 1, JM-010 component Group A; Drug: Part 2, JM-010 combination Group A; Drug: Part 1, Placebo Group; Drug: Part 2, Placebo Group; Drug: Part 1, JM-010 component Group C; Drug: Part 2, JM-010 combination Group B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04377945

BK-JM-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

41 participants in 8 patient groups, including a placebo group

Part 1, JM-010 component Group A

Experimental group

Description:

Part 1, JM-010 component Group A

Treatment:

Drug: Part 1, JM-010 component Group A

Part 1, JM-010 component Group B

Experimental group

Description:

Part 1, JM-010 component Group B

Treatment:

Drug: Part 1, JM-010 component Group B

Part 1, JM-010 component Group C

Experimental group

Description:

Part 1, JM-010 component Group C

Treatment:

Drug: Part 1, JM-010 component Group C

Part 1, Placebo Group

Placebo Comparator group

Description:

Part 1, Placebo Group

Treatment:

Drug: Part 1, Placebo Group

Part 2, JM-010 combination Group A

Experimental group

Description:

Part 2, JM-010 combination Group A

Treatment:

Drug: Part 2, JM-010 combination Group A

Part 2, JM-010 combination Group B

Experimental group

Description:

Part 2, JM-010 combination Group B

Treatment:

Drug: Part 2, JM-010 combination Group B

Part 2, JM-010 component Group C

Experimental group

Description:

Part 2, JM-010 component Group C

Treatment:

Drug: Part 2, JM-010 component Group C

Part 2, Placebo Group

Placebo Comparator group

Description:

Part 2, Placebo Group

Treatment:

Drug: Part 2, Placebo Group