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

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ClinicalTrials.gov Identifier: NCT02439203
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Contera Pharma ApS
Information provided by (Responsible Party):
Bukwang Pharmaceutical

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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Levodopa Induced Dyskinesia (LID) Drug: JM-010 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Levodopa

Arm Intervention/treatment
Experimental: JM-010
JM-010
Drug: JM-010
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 7 Days ]
    Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge


Secondary Outcome Measures :
  1. Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III [ Time Frame: 7 Days ]
    Investigator-rated Parkinsonian disability using UPDRS Part III after levodopa challenge

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

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

  4. 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 ]
    Assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439203


Locations
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South Africa
Bloemfontein, South Africa
Sponsors and Collaborators
Bukwang Pharmaceutical
Contera Pharma ApS

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Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT02439203     History of Changes
Other Study ID Numbers: JM-010CS01
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Bukwang Pharmaceutical:
Parkinson Disease
Levodopa Induced Dyskinesia (LID)
Dyskinesia

Additional relevant MeSH terms:
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Parkinson Disease
Dyskinesias
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs