Phase
Condition
Dyskinesias
Treatment
JM-010 group A
Placebos
JM-010 group B
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is able to read, understand, and provide written, dated informed consent prior toScreening 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 showsresponsiveness to levodopa.
Has experienced dyskinesia over a period of at least 3 months prior to ScreeningVisit
Has stable peak-effect dyskinesia
Has more than one hour of "ON" time with troublesome dyskinesia during daily wakinghours on a 24-hour PD subject diary
Is on a stable levodopa dosing regimen requiring at least 3 dose administrations butno more than 6 dose administrations per day
Exclusion
Exclusion Criteria:
Has undergone surgery for the treatment of PD
Has a current diagnosis of Substance Use (including alcohol) Disorder (Abuse orDependence, 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 investigatorduring the course of their participation in the study
Has current seizure disorders (other than febrile seizures in childhood) requiringtreatment with anticonvulsants.
Has known serious ongoing symptomatic cerebral disease or cerebrovascular disease orany acute brain trauma requiring treatment with anti-convulsant therapy within 5years prior Visit 2, Week 0 (Baseline Visit).
Has a history of exclusively diphasic, OFF state, myoclonic, dystonic, or akatheticdyskinesia without peak-dose dyskinesia.
Other criteria related to other medical conditions to be referred to the protocol.
Study Design
Study Description
Connect with a study center
Contera Investigational site_FR
Toulouse,
FranceSite Not Available
Contera Investigational site_DE
Rostock,
GermanySite Not Available
Contera Investigational site_IT
Roma,
ItalySite Not Available
Contera Investigational site_KOR
Seoul,
Korea, Republic ofSite Not Available
Contera Investigational site_ES
Madrid,
SpainSite Not Available
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