NCT02125825

Brief Summary

The objective is to assess a compact, portable, wireless movement disorder system with continuous monitoring capabilities to detect and quantify the severity of levodopa-induced dyskinesia in Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

April 25, 2014

Last Update Submit

January 8, 2016

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Correlation between motion sensor features and clinician-rated dyskinesia severity

    Motor function (movement speed and magnitude measured with a motion sensor) will be collected for a period of 2 hours after taking normally prescribed dose of levodopa.

    All data will be collected within a single session not to exceed 3 hours

Study Arms (1)

Parkinson's disease on levodopa

Individuals with Parkinson's disease who are taking levodopa to treat motor symptoms

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with Parkinson's disease and a history of levodopa-induced dyskinesia

You may qualify if:

  • Diagnosis of idiopathic Parkinson's disease
  • Clinical history of levodopa-induced dyskinesia
  • Years of age or older
  • Stage 2 - 4 OFF-medication on the Hoehn and Yahr scale

You may not qualify if:

  • Dementia (determined by a neuropsychological assessment)
  • Severe tremor unaffected by levodopa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 29, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(2)