Clinical trial NCT02439203: Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia
Official title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Levodopa Induced Dyskinesia (LID)
Keywords: Parkinson Disease
Levodopa Induced Dyskinesia (LID)
Dyskinesia
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Contera Pharma ApS
First posted: 2015-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Subject with a diagnosis of moderate to severe idiopathic PD with showing responsiveness to levodopa.
* All anti-Parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period.
* Subject with stable predictable peak-effect LID of at least 2 hours of the awake day and with at least moderately disabling.
* Amantadine and/or monoamine oxidase (MAO) inhibitor must be stopped at least 2 weeks prior to the start of Treatment Period 1(TP 1).

Exclusion Criteria:

* Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism, Parkinson-plus syndromes or other neurological degenerative diseases.
* History of any other brain surgery or surgery for the treatment of PD.
* Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.
* A history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of Treatment Period 1(TP1).
* A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants.
* Clinically significant abnormal laboratory data at screening.
* Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of TP1.
* History of cerebrovascular accident or transient ischemic attack, coronary vasospasm/Prinzmetal's angina.
* History of serotonin syndrome.
* Breast feeding or pregnant women.

Primary outcomes:
measure: Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS)
timeFrame: 7 Days
Secondary outcomes:
measure: Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III
timeFrame: 7 Days
measure: Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires
timeFrame: Daily
measure: Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale
timeFrame: 7 Days
measure: Safety and Tolerability as measured by assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)
timeFrame: 28 Days
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
Study officials:
References: