Phase
Condition
Dyskinesias
Parkinson's Disease
Treatment
JM-010 group A
placebos
JM-010 group B
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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.
Study Design
Study Description
Connect with a study center
Contera Investigational site_DE
Rostock,
GermanyActive - Recruiting
Charité Benjamin Franklin Berlin
Berlin, - 12203
GermanyActive - Recruiting
Universitätsklinikum Freiburg
Freiburg, - 79106
GermanyActive - Recruiting
Unversity Rostock
Rostock, - 18051
GermanyActive - Recruiting
IRCCS Fondazione Policlinico Milano
Via Francesco Sforza, Milano 20122
ItalyActive - Recruiting
IRCCS Neuromed
Via Atinense, Pozzilli 86077
ItalyActive - Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario de Burgos. Servicio de Neurolog a
Burgos, 09006
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, - 28222
SpainActive - Recruiting
Policlínica Gipuzkoa
San Sebastian, San Sebastián 20014
SpainActive - Recruiting
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