A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dyskinesias
- Parkinson Disease
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Double-blind, double-dummy.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study. Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study. Subjects will co...
This is a Phase 2, double-blind, double-dummy, placebo-controlled, randomized, parallel group, multicentre study. Subjects with a diagnosis of moderate to severe dyskinesia in Parkinson's disease (PD) will complete a Screening Visit to assess eligibility to participate in the study. Subjects will continue with their usual levodopa treatment regimen for the duration of study participation. The screening assessment period will be a minimum of 1 week up to a maximum of 6 weeks. Subjects deemed to be eligible at the end of the Screening Visit will be randomly assigned in a 1:1:1 ratio to receive either 1 of the 2 dose combinations of JM-010 and 1 placebo, or 2 placebos as per the double-dummy study design. The randomized subjects will be followed treatment periods for 12 weeks and safety follow periods for 2 weeks, including pharmacokinetic (PK) sub-study.
Tracking Information
- NCT #
- NCT03956979
- Collaborators
- Bukwang Pharmaceutical
- Investigators
- Study Director: Serena Hyun Contera Pharma
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