MDS Abstracts

Abstracts from the International Congress of Parkinson’s and Movement Disorders.

MENU 
  • Home
  • Meetings Archive
    • 2024 International Congress
    • 2023 International Congress
    • 2022 International Congress
    • MDS Virtual Congress 2021
    • MDS Virtual Congress 2020
    • 2019 International Congress
    • 2018 International Congress
    • 2017 International Congress
    • 2016 International Congress
  • Keyword Index
  • Resources
  • Advanced Search

A Human Factors Study of the DopaFuse® Delivery System

J. Harmon, S. Japp, C. Long, J. Spiridigliozzi, A. Heller, B. Heller, C. King, P. Plante, R. Draper, T. Lau, E. Heller (Bala Cynwyd, PA, USA)

Meeting: 2019 International Congress

Abstract Number: 100

Keywords: Development, Levodopa(L-dopa)

Session Information

Date: Monday, September 23, 2019

Session Title: Clinical Trials, Pharmacology and Treatment

Session Time: 1:45pm-3:15pm

Location: Agora 3 West, Level 3

Objective: SynAgile has developed the DopaFuse Delivery System to noninvasively and continuously administer oral LD/CD into the mouths of patients with PD. The System is intended to reduce fluctuation in plasma levodopa levels and the associated motor symptoms. The objective of this study is to test whether the System can be used safely by the intended users in the a planned Phase 2 clinical trial.

Background: DopaFuse is the first of a new class of drug delivery devices that reside in the mouth and that non-invasively and continuously deliver drugs to patients at a constant rate for absorption via the gastro-intestinal and/or buccal routes. The System consists of a reusable custom dental retainer, its case, and a pre-filled, single-use drug container, shown in Figures 1-3.[figure1][figure2][figure3] SynAgile conducted a single proof-of-concept study in 2015 to test the hypothesis that continuous oral delivery of LD/CD results in improved LD pharmacokinetics and reduced Off time. The study found significantly less variability in plasma LD concentration and reduced Off with continuous versus intermittent oral levodopa delivery.[1]

Method: Five patient-participant pairs were invited to participate in this formative human factors study. Each pair consisted of one patient with advanced PD along with their adult caregiver. Pairs attended a single training session followed by a one-hour decay period before testing. Testing was conducted with the patient participant alone, with the caregiver participant alone, and the patient-caregiver pair together. During each session, the participant was asked to set up the system for use, simulate use on a manikin, and store the System. Success was defined as ability to complete the tasks safely without describing or encountering difficulty. During each session, the participant was asked to set up the system for use, simulate use on a manikin, and store the System. Success was defined as ability to complete the tasks safely without describing or encountering difficulty.

Results: [figure4] At no time did any patient or caregiver perform a task in a manner likely to lead to an adverse event during the clinical trial.

Conclusion: This study suggests that patients with advanced PD and their caregivers will be able to safely use the DopaFuse Delivery System in the upcoming Phase 2 clinical trial.

Picture1

Picture2

Picture3

Picture4HF

References: [1]Warren Olanow et al. (2019), Continuous versus intermittent oral administration of levodopa in Parkinson’s disease patients with motor fluctuations: A pharmacokinetics, safety, and efficacy study. Mov Disord. doi:10.1002/mds.27610

To cite this abstract in AMA style:

J. Harmon, S. Japp, C. Long, J. Spiridigliozzi, A. Heller, B. Heller, C. King, P. Plante, R. Draper, T. Lau, E. Heller. A Human Factors Study of the DopaFuse® Delivery System [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/a-human-factors-study-of-the-dopafuse-delivery-system/. Accessed May 19, 2025.
  • Tweet
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

« Back to 2019 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/a-human-factors-study-of-the-dopafuse-delivery-system/

Most Viewed Abstracts

  • This Week
  • This Month
  • All Time
  • An Apparent Cluster of Parkinson's Disease (PD) in a Golf Community
  • Covid vaccine induced parkinsonism and cognitive dysfunction
  • What is the appropriate sleep position for Parkinson's disease patients with orthostatic hypotension in the morning?
  • The hardest symptoms that bother patients with Parkinson's disease
  • Life expectancy with and without Parkinson’s disease in the general population
  • What is the appropriate sleep position for Parkinson's disease patients with orthostatic hypotension in the morning?
  • Increased Risks of Botulinum Toxin Injection in Patients with Hypermobility Ehlers Danlos Syndrome: A Case Series
  • Insulin dependent diabetes and hand tremor
  • Improvement in hand tremor following carpal tunnel release surgery
  • Impact of expiratory muscle strength training (EMST) on phonatory performance in Parkinson's patients
  • Help & Support
  • About Us
  • Cookies & Privacy
  • Wiley Job Network
  • Terms & Conditions
  • Advertisers & Agents
Copyright © 2025 International Parkinson and Movement Disorder Society. All Rights Reserved.
Wiley