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

NCT03407378 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-06-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tools4Patient

    lead OTHER

Principal Investigators

  • Pereira Alvaro · Tools4Patient

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2020-02-07
Completion
2020-03-31

Countries

  • United States
  • Belgium
  • France

Study Locations

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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 NCT03407378 on ClinicalTrials.gov