NCT02880033

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

8.7 years

First QC Date

August 3, 2016

Last Update Submit

March 25, 2020

Conditions

Parkinson's DiseaseAmyotrophic Lateral SclerosisOxidative StressIron Overload

Keywords

Parkinson's diseaseAmyotrophic lateral sclerosisPeripheral blood mononuclear cellsex vivo model for oxidative stressiron metabolism and chelation

Outcome Measures

Primary Outcomes (1)

  • hydroxyl radical measured

    hydroxypethidine probe with Fluorescence-activated cell sorting

    12 months

Secondary Outcomes (4)

  • adenosine triphosphate production measured by seahorse

    12 months

  • oxygen consumption measured by seahorse

    12 months

  • free reactive iron (ferrous iron)

    12 months

  • lipid peroxidation measured by Fluorescence-activated cell sorting

    12 months

Study Arms (3)

Parkinson's disease

ACTIVE COMPARATOR

ex vivo analysis of lymphocytes from 30 patients with Parkinson's disease with deferiprone and placebo treatment

Drug: deferiproneDrug: placebo

Amyotrophic lateral sclerosis

ACTIVE COMPARATOR

ex vivo analysis of lymphocytes from 30 patients with Amyotrophic lateral sclerosis with deferiprone and placebo treatment

Drug: deferiproneDrug: placebo

healthy age and sex matched controls

PLACEBO COMPARATOR

ex vivo analysis of lymphocytes from 30 healthy age and sex matched controls with deferiprone and placebo treatment

Drug: deferiproneDrug: placebo

Interventions

deferiproneDRUG

to test the action of deferiprone on lymphocytes from patients and controls ex vivo

Also known as: FERRIPROX
Amyotrophic lateral sclerosisParkinson's diseasehealthy age and sex matched controls
placeboDRUG

to control the action of placebo on lymphocytes from patients and controls ex vivo

Amyotrophic lateral sclerosisParkinson's diseasehealthy age and sex matched controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease according to Movement Disorders Society criteria
  • Amyotrophic Lateral Sclerosis according to El escorial criteria
  • Age and sex matched healthy controls

You may not qualify if:

  • Severe comorbidities (cancer, other degenerative diseases, hemopathy, inflammatory diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Parkinson DiseaseAmyotrophic Lateral SclerosisIron Overload

Interventions

Deferiprone

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSpinal Cord DiseasesMotor Neuron DiseaseTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism Disorders

Intervention Hierarchy (Ancestors)

PyridonesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David DEVOS, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2016

First Posted

August 26, 2016

Study Start

February 1, 2011

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)