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

Parkinson's Disease Clinical Trial

— LID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02439203
• Other study ID #: JM-010CS01
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2015
• Last updated: January 11, 2016
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyskinesias
• Levodopa Induced Dyskinesia (LID)
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• JM-010

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical	Contera Pharma ApS

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS)	Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge	7 Days	No
Secondary	Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III	Investigator-rated Parkinsonian disability using UPDRS Part III after levodopa challenge	7 Days	No
Secondary	Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires	Subject-rated change in PD effects as assessed through daily dyskinesia questionnaires	Daily	No
Secondary	Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale	Subject-rated change in dyskinesia severity as assessed by the CGI scale	7 Days	No
Secondary	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)	Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)	28 Days	Yes