Human Factors Validation Protocol

Human Factors Validation Protocol

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Observational
Eligible Ages: 18 - 100 Status: Enrolling by invitation
Time Since Diagnosis: Any may be eligible Study Focus:

Study Purpose:

The purpose of this research is to evaluate a new pen injector device which may be used for the administration of a drug called, APOKYN® (apomorphine hydrochloride injection).

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More Details

APOKYN has been approved by the Food and Drug Administration (FDA) to treat loss of control of body movements in people with advanced Parkinson’s disease. This study will involve people with Parkinson’s, and people who are caregivers for people with Parkinson’s. This research will be focused on the usability of the pen injector device and will be a simulated use study. This means you will perform tasks associated with the use of the pen injector device. You will NOT be asked to use any part of the device on yourself or administer it to anyone else. The research company will collect data and feedback on the use of the new pen injector device during your study sessions.

Phase: Observational Lead Sponsor: US WorldMeds
Trial ID: 005149 Sponsor Type: Industry
Primary Country: United States Additional Collaborators or Sponsors:
Estimated Enrollment: 60 Study Start Date: February 2018
Estimated Study Completion Date: March 2018 Source:
Study Website: N/A
This is a FDA Regulated Trial

More Inclusion & Exclusion Criteria

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