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Iron chelation in the prevention of secondary degeneration after stroke
EU CTIS ID: 2024-514230-20-00
What this study is testing
To compare, in patients with proximal occlusion of the sylvian artery, the effect of prolonged treatment (6 months) with defereriprone (Ferriprox®) given daily at a low dose (30mg/Kg/d) from J3-J5, on the evolution of the iron accumulation (95th percentile of R2 values) between an initial MRI (J5) and at 6 months within the homolateral black substance and initially spared by the infarction, compared to the values measured without treatment in our previous work.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 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
You likely can't join if
- - Contraindication to MRI
- - 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
See the full eligibility 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 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
- - Contraindication to MRI
- - 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 and within 1 month after the final evaluation
- - Patient with history of Parkinson's disease symptoms (tremor at rest, bradykinesia, rigidity, postural dysfunction, gait abnormalities, loss of balance), exclusion criterion due to the association of Deferiprone with worse outcome in patients with early Parkinson's disease according to the FAIRPARK-II Study Group
- - Kidney or liver failure
- - Pregnant or breast feeding women
- - Patient in an emergency situation
- - Patient under permanent guardianship
- - Patient subject to a safeguard measure of justice
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.