Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT02439203
• Date of registration: 30/04/2015
• Prospective Registration: Yes
• Primary sponsor: Bukwang Pharmaceutical
• Public title: Efficacy and Safety of JM-010 in PD With Levodopa-Induced Dyskinesia LID
• Scientific 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
• Date of first enrolment: May 2015
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02439203
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

South Africa

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Levodopa Induced Dyskinesia (LID)

Parkinson's Disease

Intervention(s)

Drug: Placebo

Drug: JM-010

Primary Outcome(s)

Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS) [Time Frame: 7 Days]

Secondary Outcome(s)

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) [Time Frame: 28 Days]

Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale [Time Frame: 7 Days]

Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III [Time Frame: 7 Days]

Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires [Time Frame: Daily]

Secondary ID(s)

JM-010CS01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Contera Pharma ApS