Iron Chelation in the Prevention of Secondary Degeneration After Stroke

NCT05111821 | Terminated Phase 2 DMC

• 1 other identifier: CHUBX 2019/49
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke is a major cause of disability over the world. While acute therapies have made huge progresses, the number of survivors leaving with clinical consequences of stroke is increasing. Beyond stroke itself, secondary neurodegeneration of disconnected areas, especially of central hubs such as the substantia nigra or the thalamus, could significantly impact the overall outcome of the patients. Data have identified iron accumulation within the disconnected areas as potentially accelerating neurodegeneration. In this research, the main objective is test whether long-term chelation through Deferiprone (Ferrirpox®, Chiesi) administered daily from 3-to-5 days following stroke to 6 months could avoid iron accumulation as measured with Magnetic resonance imaging (MRI) within disconnected areas (substantia nigra). MRI imaging methods such as the quantification of the transverse relaxation rate R2\* provide highly correlated information to the histologically measured iron load

Conditions

Stroke

Keywords

Stroke; Deferiprone; Iron accumulation; Magnetic Resonance Imaging; Neuroprotective treatment

Outcome Measures

Primary Outcomes (2)

• R2* Index within the homolateral black substance

  Iron load : 95th percentile of the values of MRI R2\*

  Day 1

• R2* Index within the homolateral black substance

  Iron load : 95th percentile of the values of MRI R2\*

  6 Month

Secondary Outcomes (22)

• R2* Index within the thalamus and the middle nucleus of the homolateral thalamus

  Day 1

• R2* Index within the thalamus and the middle nucleus of the homolateral thalamus

  6 Month

• R2* Relaxivity values

  Day 1

• R2* Relaxivity values

  6 Month

• Fugl-Meyer Score

  Day 1

Study Arms (2)

Deferiprone

EXPERIMENTAL

Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d

Procedure: Magnetic Resonance Imaging (MRI); Drug: Deferiprone treatment

Treatment As usual

ACTIVE COMPARATOR

Patients followed during 6 months according to standard care

Procedure: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI) PROCEDURE

Quantification of iron will be performed through Magnetic Resonance Imaging

Deferiprone; Treatment As usual

Deferiprone treatment DRUG

Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d

Deferiprone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years old.
• Covered by a social insurance
• With a stroke involving the deep territory of the middle cerebral artery (including at least half of the volume of the striatum) due to occlusion of the carotid artery or of proximal M1 or M2 segments. The artery can be occluded when the patient is admitted at the acute phase or already recanalized as soon as the striatum is involved.
• Absolute neutrophil count ≥1.5 x109/L.
• For women of childbearing potential, negative β HCG test and highly effective contraception (oestroprogestative contraception, intra-uterine device, bilateral salpingectomy) to be continued 6 months after the last administration of deferiprone.
• Men whose partner provides a highly effective contraception or who accept to use a contraception method (condom) while treated by deferiprone and to continue 90 days after the last administration of deferiprone
• Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial. Patients unable to give their personal consent (severe aphasia, impaired understanding or attention induced by the infarction) may be included with the consent by a trusted person provided in article L. 1111-6, by the family or by a person who has a close and stable relationship with the person concerned. The person concerned is informed as soon as possible and his consent is sought during visit at 3 month or 6 month if he regains his capacity to consent. These patients may be included because the treatment may be provided by the caregiver, or a home nurse for patients alone or for whom the caregiver is unable to follow the treatment. Most severe patients, in rehabilitation structure will have support for taking treatment and monitoring it

You may not qualify if:

• Contraindication to MRI.
• Pregnant or breast feeding women.
• Inability to swallow correctly (required for oral treatment).
• History of symptomatic cerebral infarct or hemorrhage.
• Pre-stroke modified Rankin Scale \[mRS\] score\>2).
• History of severe cognitive impairment (dementia).
• History of recent (within the past 6 months) and evolving psychiatric disorders matching to axis 1 of the DSM-IV criteria.
• History of stroke directly involving substantia nigra or thalamus.
• Microbleed, or past hematoma involving substantia nigra; past hematoma involving thalamus.
• PH1 or PH2 hemorrhagic transformation.
• Hypersensitivity to Deferiprone or any of the excipients mentioned in section 6.1 of the Summary of Product characteristics of Ferriprox
• Patients with agranulocytosis or with a history of agranulocytosis.
• Patients with history of relapsing neutropenia.
• Patient with immunosuppression condition.
• Due to the risk of agranulocytosis caused by Deferiprone and the unknown mechanism by which this agranulocytosis is induced, combining Deferiprone with other medicinal products known to cause agranulocytosis will not be allowed. Such medicinal products include clozapine as well as some NSAIDs (e.g. Phenylbutazone or Metamizole), antithyroid agents, sulfonamide antibiotics or metothrexate.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU Bordeaux

Bordeaux, 33 076, France

Location

CHU de Lille

Lille, 59000, France

Location

MeSH Terms

Conditions

Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Thomas TOURDIAS

  University Hospital, Bordeaux

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: November 8, 2021
• Study Start: June 8, 2022
• Primary Completion: April 17, 2025
• Study Completion: April 22, 2025
• Last Updated: July 21, 2025

Record last verified: 2025-07

Locations

FR (2)