110
Participants
Start Date
June 26, 2018
Primary Completion Date
February 7, 2020
Study Completion Date
March 31, 2020
IPT803
Administration of IPT803 three times a day for 12 weeks as add-on therapy to patient regular PD medication(s) or as a new therapy for drug naïve patients.
Optional pharmacogenetic assessment
Blood sample of 3 milliliters for genotyping assessment (according to patient consent).
Questionnaires
Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)
Optional Blood-Oxygen-level Dependent functionalMRI
BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)
Motor Assessments before taking regular PD treatment
Regular PD treatment stopped 12 or 24 hours prior to Visits 2, 3 and 4 depending on the drug form (extended vs standard release). Motor assessments using UPDRS Part III are performed when patients are OFF regular PD treatment. Regular PD treatment is taken on site during the visit after the motor assessments are performed.
Motor Assessments on regular PD treatment
Regular PD treatment is not modified before the visits. The motor assessments using UPDRS Part III are performed while the patient is on regular PD treatment.
CHU Liege - Liège University, Liège
Columbia, New York
CHU Purpan - Hopital Pierre Paul Riquet, Toulouse
University of Florida, Gainesville
CHU Rennes - Hopital Pontchaillou, Rennes
CHU Grenoble, Grenoble
Henry Ford, West Bloomfield
Northwestern, Chicago
University of Colorado School of Medicine, Aurora
CHU Poitiers, Poitiers
Tools4Patient
OTHER