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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Contera Pharma
• Collaborator: Bukwang Pharmaceutical

Criteria

Inclusion Criteria:

• Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.

• Is male or female, between 18 and 80 years of age at Screening Visit.

• Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria and requires treatment with and shows responsiveness to levodopa.

• Has experienced dyskinesia over a period of at least 3 months prior to Screening Visit

• Has stable peak-effect dyskinesia

• Has more than one hour of "ON" time with troublesome dyskinesia during daily waking hours on a 24-hour PD subject diary

• Is on a stable levodopa dosing regimen requiring at least 3 dose administrations but no more than 6 dose administrations per day

Exclusion Criteria:

• Has undergone surgery for the treatment of PD

• Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse or Dependence, as defined by Diagnostic and Statistical Manual, Fifth Edition [DSM 5]),

• Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses

• Has a significant risk for suicidal behaviour in the opinion of the investigator during the course of their participation in the study

• Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anticonvulsants.

• Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease or any acute brain trauma requiring treatment with anti-convulsant therapy within 5 years prior Visit 2, Week 0 (Baseline Visit).

• Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akathetic dyskinesia without peak-dose dyskinesia.

Other criteria related to other medical conditions to be referred to the protocol.