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

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

June 16, 2021

Primary Completion Date

July 21, 2022

Study Completion Date

August 2, 2022

Conditions
Parkinson's Disease
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.

Trial Locations (5)

28938

Neuroscience Centre (CINAC), Móstoles

03043

San Raffaele Cassino, Cassino

00133

Centro Parkinson, Policlinico Tor Vergata, Rome

00163

IRCCS San Raffaele Pisana, Rome

Unknown

Centre Hospitalier de Luxembourg, Luxembourg

All Listed Sponsors
collaborator

Clintrex Research Corporation

UNKNOWN

collaborator

TFS Trial Form Support

INDUSTRY

collaborator

Clinical Data Science GmbH

UNKNOWN

lead

SynAgile Corporation

INDUSTRY