NCT03956979

A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson's Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations of JM-010

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Contera Pharma · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The current study will explore the efficacy, safety and tolerability of 2 dose combinations of JM-010 to determine the optimal doses of each component to be studied in confirmatory clinical trials.

Detailed 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 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.

Conditions

• Dyskinesias

Interventions

Type	Name	Description
DRUG	JM-010 group A	JM-010 fixed combination drug (Group A) + Placebo 2
DRUG	JM-010 group B	JM-010 fixed combination drug (Group B) + Placebo 1
DRUG	Placebos	Placebo 1 + Placebo 2

Timeline

• Start date: 2019-07-22
• Primary completion: 2024-03-07
• Completion: 2024-03-21
• First posted: 2019-05-21
• Last updated: 2024-06-17

Locations

5 sites across 5 countries: France, Germany, Italy, South Korea, Spain