Overview

This trial is active, not recruiting.

Conditions parkinson's disease, amyotrophic lateral sclerosis, oxidative stress, iron overload
Treatments deferiprone, placebo
Sponsor University Hospital, Lille
Start date February 2011
End date February 2016
Trial size 90 participants
Trial identifier NCT02880033, 2010-A01216-33, 2010_29

Summary

Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development.

The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo.

PBMC and platelets will be stored for future analyses.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
ex vivo analysis of lymphocytes from 30 patients with Parkinson's disease with deferiprone and placebo treatment
deferiprone FERRIPROX
to test the action of deferiprone on lymphocytes from patients and controls ex vivo
placebo
to control the action of placebo on lymphocytes from patients and controls ex vivo
(Active Comparator)
ex vivo analysis of lymphocytes from 30 patients with Amyotrophic lateral sclerosis with deferiprone and placebo treatment
deferiprone FERRIPROX
to test the action of deferiprone on lymphocytes from patients and controls ex vivo
placebo
to control the action of placebo on lymphocytes from patients and controls ex vivo
(Placebo Comparator)
ex vivo analysis of lymphocytes from 30 healthy age and sex matched controls with deferiprone and placebo treatment
deferiprone FERRIPROX
to test the action of deferiprone on lymphocytes from patients and controls ex vivo
placebo
to control the action of placebo on lymphocytes from patients and controls ex vivo

Primary Outcomes

Measure
hydroxyl radical measured
time frame: 12 months

Secondary Outcomes

Measure
adenosine triphosphate production measured by seahorse
time frame: 12 months
oxygen consumption measured by seahorse
time frame: 12 months
free reactive iron (ferrous iron)
time frame: 12 months
lipid peroxidation measured by Fluorescence-activated cell sorting
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Parkinson's disease according to Movement Disorders Society criteria - Amyotrophic Lateral Sclerosis according to El escorial criteria - Age and sex matched healthy controls Exclusion Criteria: - Severe comorbidities (cancer, other degenerative diseases, hemopathy, inflammatory diseases)

Additional Information

Official title Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis
Principal investigator David DEVOS, MD, PhD
Description The study collection of PBMC and platelets from 30 patient having Parkinson's disease 30 patients having Amyotrophic lateral sclerosis and 30 healthy controls. The collection will be performed either by cytapheresis for half of the patient and by collecting the whole blood for the other half. PBMC and platelets will be stored at minus 80°C. PBMC of patients and controls are exposed ex vivo to different pathological condition (mainly Hydrogen peroxide, menadione, hypoxia...) with and without deferiprone to analyse whether the level of oxidative stress (Reactive Oxygen Species and notably hydroxyl radical with hydroxypethidine probe with flow cytometry) is reduced under deferiprone (primary criterion. Secondary analyses will concern the level of iron, the energy metabolism (aerobic versus anaerobic and the level of Adenosine triphosphate production), the type of cell death (apoptosis, autophagy and new programmed cell death: Ferroptosis) and inflammation. Finally, the level of growth factors and their effectiveness will be studied from platelets.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University Hospital, Lille.