A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson’s Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components
clinical trial of JM-010 in patients with Parkinsons’ Disease.
– Is able to read, understand, and provide written, dated informed consent prior to
– 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
– 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 behavior 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.
- Bukwang Investigator site, Fountain Valley, California, United States, 92704
- Bukwang Investigator site, Fullerton, California, United States, 92835
- Bukwang Investigator site, Sacramento, California, United States, 95817