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Assessing the Pharmacokinetics, Safety, Tolerability and Efficacy of Continuous Oral Levodopa Via the DopaFuse® Delivery System in Parkinson's Disease Patients

NCT04778176 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-08-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether the DopaFuse System can reduce the fluctuation of plasma levodopa levels compared to participants' standard intermittent doses of oral LD/CD tablets (background treatment). It will also assess whether the system is safe, well tolerated, and can relieve motor symptoms.

Conditions

Interventions

COMBINATION_PRODUCT

continuous oral delivery of levodopa/carbidopa

The system consists of a reusable custom dental retainer, its case, and a pre-filled, single-use container which continuously releases levodopa/carbidopa into the back of the mouth.

Sponsors & Collaborators

  • Clintrex Research Corporation

    collaborator UNKNOWN

  • TFS Trial Form Support

    collaborator INDUSTRY

  • Clinical Data Science GmbH

    collaborator UNKNOWN

  • SynAgile Corporation

    lead INDUSTRY

Principal Investigators

  • Ephraim Heller, MBA · SynAgile Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2022-07-21
Completion
2022-08-02

Countries

  • Italy
  • Luxembourg
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778176 on ClinicalTrials.gov