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TerminatedNCT05111821CHEL-ICUpdated Jul 21, 2025

Iron Chelation in the Prevention of Secondary Degeneration After Stroke

A Phase 2 interventional study of Magnetic Resonance Imaging (MRI) and Deferiprone treatment in Stroke, sponsored by University Hospital, Bordeaux. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-21.

Sponsored by University Hospital, Bordeaux · Phase 2, Interventional, and Treatment

Why this study was terminated
Recent publications have raised questions about the validity of the research hypothesis, potentially altering the anticipated benefit-risk balance. Furthermore, recruitment and patient adherence to the protocol have proven insufficient.
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • Deferiprone
  • Iron accumulation
  • Magnetic Resonance Imaging
  • Neuroprotective treatment
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 11 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Patients with anaemia (regardless of latter aetiology) or a history of another haematological disease.
  • Participation in another drug study (Investigational medical product) within 1 month prior to inclusion in the study.
  • Kidney or liver failure.
  • Patient in an emergency situation
  • Patient under permanent guardianship.
  • Patient subject to a safeguard measure of justice
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Deferiprone

    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

  • Active comparator
    Treatment As usual

    Patients followed during 6 months according to standard care

    Procedure: Magnetic Resonance Imaging (MRI)

Interventions

  • ProcedureMagnetic Resonance Imaging (MRI)

    Quantification of iron will be performed through Magnetic Resonance Imaging

  • DrugDeferiprone treatment

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

06

What researchers measure

Primary outcomes

  1. R2* Index within the homolateral black substance

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

    Time frame: Day 1

  2. R2* Index within the homolateral black substance

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

    Time frame: 6 Month

Secondary outcomes

  1. R2* Index within the thalamus and the middle nucleus of the homolateral thalamus

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

    Time frame: Day 1

  2. R2* Index within the thalamus and the middle nucleus of the homolateral thalamus

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

    Time frame: 6 Month

  3. R2* Relaxivity values

    R2\* relaxivity values (95th percentile) measured on MRI

    Time frame: Day 1

  4. R2* Relaxivity values

    R2\* relaxivity values (95th percentile) measured on MRI

    Time frame: 6 Month

  5. Fugl-Meyer Score

    Fugl Meyer Upper Limb Motor Scale assesses tone, strength and motor of upper limbs. The total score is on 66 points for the upper limbs to which the evaluation will be limited. A higher score indicates better motor performance. The test time is about 20 minutes.

    Time frame: Day 1

  6. Fugl-Meyer Score

    Fugl Meyer Upper Limb Motor Scale assesses tone, strength and motor of upper limbs. The total score is on 66 points for the upper limbs to which the evaluation will be limited. A higher score indicates better motor performance. The test time is about 20 minutes.

    Time frame: 3 Month

  7. Fugl-Meyer Score

    Fugl Meyer Upper Limb Motor Scale assesses tone, strength and motor of upper limbs. The total score is on 66 points for the upper limbs to which the evaluation will be limited. A higher score indicates better motor performance. The test time is about 20 minutes.

    Time frame: 6 Month

  8. Box and Block test Score

    Manual dexterity of the upper limbs. The test consists of a 2-compartment box containing 150 blocks in one compartment. The patient must pass the maximum number of blocks to the second compartment in 1 minute. The maximum score is 150. A higher score indicates better manual dexterity. The score is evaluated for the right hand and left hand. The test duration is 5 minutes.

    Time frame: Day 1

  9. Box and Block test Score

    Manual dexterity of the upper limbs. The test consists of a 2-compartment box containing 150 blocks in one compartment. The patient must pass the maximum number of blocks to the second compartment in 1 minute. The maximum score is 150. A higher score indicates better manual dexterity. The score is evaluated for the right hand and left hand. The test duration is 5 minutes.

    Time frame: 3 Month

  10. Box and Block test Score

    Manual dexterity of the upper limbs. The test consists of a 2-compartment box containing 150 blocks in one compartment. The patient must pass the maximum number of blocks to the second compartment in 1 minute. The maximum score is 150. A higher score indicates better manual dexterity. The score is evaluated for the right hand and left hand. The test duration is 5 minutes.

    Time frame: 6 Month

  11. Modified Rankin scale Score

    Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability

    Time frame: Day 1

  12. Modified Rankin scale Score

    Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability

    Time frame: 3 Month

  13. Modified Rankin scale Score

    Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability

    Time frame: 6 Month

  14. Montreal cognitive assessment (MoCA) Score

    Cognitive functions evaluation in the areas of attention, concentration, executive functions, episodic memory, language, constructive visual practices, abstract abilities, computation and orientation. The maximum score is 30 points and the pathological threshold is 26/30. The duration of passing is about 15 minutes.

    Time frame: Day 1

  15. Montreal cognitive assessment (MoCA) Score

    Cognitive functions evaluation in the areas of attention, concentration, executive functions, episodic memory, language, constructive visual practices, abstract abilities, computation and orientation. The maximum score is 30 points and the pathological threshold is 26/30. The duration of passing is about 15 minutes.

    Time frame: 3 Month

  16. Montreal cognitive assessment (MoCA) Score

    Cognitive functions evaluation in the areas of attention, concentration, executive functions, episodic memory, language, constructive visual practices, abstract abilities, computation and orientation. The maximum score is 30 points and the pathological threshold is 26/30. The duration of passing is about 15 minutes.

    Time frame: 6 Month

  17. Center for epidemiologic studies depression scale (CES-D)

    Existence of a depressive syndrome. It consists of 20 moral status questions in the previous week that the patient answers on a 6-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 20 questions and ranges from 0 to 60. The score is higher the more severe the depressive disorders. The depressive threshold is typically considered to be \>23 in women and \>17 in men. The transfer time is about 10 minutes.

    Time frame: Day 1

  18. Center for epidemiologic studies depression scale (CES-D)

    Existence of a depressive syndrome. It consists of 20 moral status questions in the previous week that the patient answers on a 6-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 20 questions and ranges from 0 to 60. The score is higher the more severe the depressive disorders. The depressive threshold is typically considered to be \>23 in women and \>17 in men. The transfer time is about 10 minutes.

    Time frame: 3 Month

  19. Center for epidemiologic studies depression scale (CES-D)

    Existence of a depressive syndrome. It consists of 20 moral status questions in the previous week that the patient answers on a 6-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 20 questions and ranges from 0 to 60. The score is higher the more severe the depressive disorders. The depressive threshold is typically considered to be \>23 in women and \>17 in men. The transfer time is about 10 minutes.

    Time frame: 6 Month

  20. Generalized anxiety disorder scale (GAD-7) scale

    Anxiety disorders assessment through 7 questions on items related to anxiety experienced during the previous 14 days that the patient answers on a 4-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 7 questions and ranges from 0 to 21. The higher the score, the more severe the anxiety disorders. The thresholds are usually: 0-4 points = no anxiety; 5-9 points = mild anxiety; 10-14 points = moderate anxiety; 15-21 points = severe anxiety. The transfer time is 5 to 10 minutes.

    Time frame: Day 1

  21. Generalized anxiety disorder scale (GAD-7) scale

    Anxiety disorders assessment through 7 questions on items related to anxiety experienced during the previous 14 days that the patient answers on a 4-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 7 questions and ranges from 0 to 21. The higher the score, the more severe the anxiety disorders. The thresholds are usually: 0-4 points = no anxiety; 5-9 points = mild anxiety; 10-14 points = moderate anxiety; 15-21 points = severe anxiety. The transfer time is 5 to 10 minutes.

    Time frame: 3 Month

  22. Generalized anxiety disorder scale (GAD-7) scale

    Anxiety disorders assessment through 7 questions on items related to anxiety experienced during the previous 14 days that the patient answers on a 4-level Likert scale that are then converted into points. The score corresponds to the sum of the points for the 7 questions and ranges from 0 to 21. The higher the score, the more severe the anxiety disorders. The thresholds are usually: 0-4 points = no anxiety; 5-9 points = mild anxiety; 10-14 points = moderate anxiety; 15-21 points = severe anxiety. The transfer time is 5 to 10 minutes.

    Time frame: 6 Month

07

Study locations

2 sites
  • CHU Bordeaux
    Bordeaux, 33 076, France
  • CHU de Lille
    Lille, 59000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05111821
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Nov 8, 2021
Start date
Jun 8, 2022
Primary completion
Apr 17, 2025
Completion
Apr 22, 2025
Last update
Jul 21, 2025

Study contacts

Thomas TOURDIAS
study director · University Hospital, Bordeaux

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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