StrokePhase 2CHEL-ICNCT05111821
Iron Chelation in the Prevention of Secondary Degeneration After Stroke
A Phase 2 study testing Magnetic Resonance Imaging (MRI) and Deferiprone treatment in people with Stroke, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Deferiprone treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Jun 2022to 22 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Long-term Iron Chelation in the Prevention of Secondary Remote Degeneration After Stroke
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
- Being tested
- Magnetic Resonance Imaging (MRI), Deferiprone treatment
- Keywords
- Stroke, Deferiprone, Iron accumulation, Magnetic Resonance Imaging, Neuroprotective treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Quantification of iron will be performed through Magnetic Resonance Imaging
Deferiprone treatmentDrug
Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| Deferiprone | Experimental | Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d Receives: Procedure: Magnetic Resonance Imaging (MRI); Drug: Deferiprone treatment |
| Treatment As usual | Active comparator | Patients followed during 6 months according to standard care Receives: Procedure: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
R2* Index within the homolateral black substance
Iron load : 95th percentile of the values of MRI R2*
Measured: Day 1
R2* Index within the homolateral black substance
Iron load : 95th percentile of the values of MRI R2*
Measured: 6 Month
Secondary outcomes (22)
R2* Index within the thalamus and the middle nucleus of the homolateral thalamus
Iron load : 95th percentile of the values of MRI R2*
Measured: Day 1
R2* Index within the thalamus and the middle nucleus of the homolateral thalamus
Iron load : 95th percentile of the values of MRI R2*
Measured: 6 Month
R2* Relaxivity values
R2* relaxivity values (95th percentile) measured on MRI
Measured: Day 1
R2* Relaxivity values
R2* relaxivity values (95th percentile) measured on MRI
Measured: 6 Month
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.
Measured: Day 1
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.
Measured: 3 Month
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.
Measured: 6 Month
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.
Measured: Day 1
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.
Measured: 3 Month
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.
Measured: 6 Month
Modified Rankin scale Score
Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability
Measured: Day 1
Modified Rankin scale Score
Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability
Measured: 3 Month
Modified Rankin scale Score
Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability
Measured: 6 Month
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.
Measured: Day 1
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.
Measured: 3 Month
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.
Measured: 6 Month
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.
Measured: Day 1
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.
Measured: 3 Month
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.
Measured: 6 Month
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.
Measured: Day 1
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.
Measured: 3 Month
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.
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start8 Jun 2022
- Primary completion17 Apr 2025
- Study completion22 Apr 2025
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas TOURDIAS, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111821
- Sponsor's protocol ID
- CHUBX 2019/49
- Acronym
- CHEL-IC
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2021
- Last updated
- 21 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Iron Chelation in the Prevention of Secondary Remote Degeneration After Stroke
- ClinicalTrials.gov ID
- NCT05111821
- Acronym / sponsor ID
- CHEL-IC / CHUBX 2019/49
- Conditions
- Stroke
- Keywords
- Stroke, Deferiprone, Iron accumulation, Magnetic Resonance Imaging, Neuroprotective treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferiprone | Experimental | Procedure: Magnetic Resonance Imaging (MRI), Drug: Deferiprone treatmentPatients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d |
| Treatment As usual | Active comparator | Procedure: Magnetic Resonance Imaging (MRI)Patients followed during 6 months according to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Quantification of iron will be performed through Magnetic Resonance Imaging | Procedure or surgery | Deferiprone, Treatment As usual |
| Deferiprone treatmentPatients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d | Drug | Deferiprone |
Primary outcome
R2* Index within the homolateral black substance
Time frame: Day 1
Iron load : 95th percentile of the values of MRI R2*
R2* Index within the homolateral black substance
Time frame: 6 Month
Iron load : 95th percentile of the values of MRI R2*
22 secondary outcomes
R2* Index within the thalamus and the middle nucleus of the homolateral thalamus
Time frame: Day 1
R2* Index within the thalamus and the middle nucleus of the homolateral thalamus
Time frame: 6 Month
R2* Relaxivity values
Time frame: Day 1
R2* Relaxivity values
Time frame: 6 Month
Fugl-Meyer Score
Time frame: Day 1
Fugl-Meyer Score
Time frame: 3 Month
Fugl-Meyer Score
Time frame: 6 Month
Box and Block test Score
Time frame: Day 1
Box and Block test Score
Time frame: 3 Month
Box and Block test Score
Time frame: 6 Month
Modified Rankin scale Score
Time frame: Day 1
Modified Rankin scale Score
Time frame: 3 Month
Modified Rankin scale Score
Time frame: 6 Month
Montreal cognitive assessment (MoCA) Score
Time frame: Day 1
Montreal cognitive assessment (MoCA) Score
Time frame: 3 Month
Montreal cognitive assessment (MoCA) Score
Time frame: 6 Month
Center for epidemiologic studies depression scale (CES-D)
Time frame: Day 1
Center for epidemiologic studies depression scale (CES-D)
Time frame: 3 Month
Center for epidemiologic studies depression scale (CES-D)
Time frame: 6 Month
Generalized anxiety disorder scale (GAD-7) scale
Time frame: Day 1
Generalized anxiety disorder scale (GAD-7) scale
Time frame: 3 Month
Generalized anxiety disorder scale (GAD-7) scale
Time frame: 6 Month
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas TOURDIAS study director
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnetic Resonance Imaging (MRI) and Deferiprone treatment in people with Stroke, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R2* Index within the homolateral black substance (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2025.