A Study to Investigate a New Treatment in Patients With Parkinson's Disease

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

June 26, 2018

Primary Completion Date

February 7, 2020

Study Completion Date

March 31, 2020

Conditions
Parkinson Disease
Interventions
DRUG

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.

GENETIC

Optional pharmacogenetic assessment

Blood sample of 3 milliliters for genotyping assessment (according to patient consent).

OTHER

Questionnaires

Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)

OTHER

Optional Blood-Oxygen-level Dependent functionalMRI

BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)

OTHER

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.

OTHER

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.

Trial Locations (10)

4000

CHU Liege - Liège University, Liège

10032

Columbia, New York

31059

CHU Purpan - Hopital Pierre Paul Riquet, Toulouse

32607

University of Florida, Gainesville

35033

CHU Rennes - Hopital Pontchaillou, Rennes

38043

CHU Grenoble, Grenoble

48322

Henry Ford, West Bloomfield

60611

Northwestern, Chicago

80045

University of Colorado School of Medicine, Aurora

86021

CHU Poitiers, Poitiers

All Listed Sponsors
lead

Tools4Patient

OTHER

NCT03407378 - A Study to Investigate a New Treatment in Patients With Parkinson's Disease | Biotech Hunter | Biotech Hunter