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CompletedNCT02439203LIDUpdated Jan 13, 2016

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

A Phase 2 interventional study of JM-010 and Placebo in Parkinson's Disease and Levodopa Induced Dyskinesia (LID), sponsored by Bukwang Pharmaceutical. Completed at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-13.

Sponsored by Bukwang Pharmaceutical · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

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

Keywords

  • Parkinson Disease
  • Levodopa Induced Dyskinesia (LID)
  • Dyskinesia
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Bukwang Pharmaceutical is the lead sponsor of 34 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    JM-010

    JM-010

    Drug: JM-010

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugJM-010
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 7 Days

Secondary outcomes

  1. 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

    Time frame: 7 Days

  2. Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires

    Subject-rated change in PD effects as assessed through daily dyskinesia questionnaires

    Time frame: Daily

  3. 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

    Time frame: 7 Days

  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)

    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

07

Study locations

1 site
  • Bloemfontein, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02439203
Lead sponsor
Bukwang Pharmaceutical
Collaborators
Contera Pharma ApS
Responsible party
Sponsor
First posted
May 8, 2015
Start date
May 2015
Primary completion
Dec 2015
Completion
Jan 2016
Last update
Jan 13, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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