NCT02439203

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

April 30, 2015

Last Update Submit

January 11, 2016

Conditions

Parkinson's DiseaseLevodopa Induced Dyskinesia (LID)

Keywords

Parkinson DiseaseLevodopa Induced Dyskinesia (LID)Dyskinesia

Outcome Measures

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

    7 Days

Secondary Outcomes (4)

  • Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III

    7 Days

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

    Daily

  • Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale

    7 Days

  • 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)

    28 Days

Study Arms (2)

JM-010

EXPERIMENTAL

JM-010

Drug: JM-010

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

JM-010DRUG
JM-010
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bloemfontein, South Africa

Location

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

January 13, 2016

Record last verified: 2016-01

Locations

ZA(1)