NCT03407378

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

A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Tools4Patient · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-26
• Primary completion: 2020-02-07
• Completion: 2020-03-31
• First posted: 2018-01-23
• Last updated: 2020-06-16

Locations

10 sites across 3 countries: United States, Belgium, France