A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA
A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiA
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.
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.
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.