Stroke
Conditions
Interventions
Trade Name: Ferriprox 500 mg comprimés pelliculés
Product Name: Ferriprox 500 mg comprimés pelliculés
Product Code: Ferriprox 500 mg comprimés pelliculés
Pharmaceutical Form: Tablet
INN or Proposed IN
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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 ß HCG test and effective contraception. - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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. - 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. - Kidney or liver failure. - Patient in an emergency situation - Patient under permanent guardianship. - Patient subject to a safeguard measure of justice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: To compare the effect of prolonged treatment (6 months) with defereriprone (Ferriprox®) given daily at low dose (30mg/Kg/d) from J3-J5, on : - evolution of iron accumulation (95th percentile of R2* values) between an initial MRI (J5) and 6 months within the homolateral thalamus and initially spared by the infarction, compared to the values measured without treatment in our previous work. - clinical performance measured at 6 months (and 3 months) between patients treated with defereriprone and untreated patients (effect difference and confidence interval of difference). To compare voxel to voxel the evolution of the iron load (95th percentile of R2* values and QSM measurements) between an initial MRI (J5) and at 6 months after a sylvian infarction within the black substance, thalamus and the whole brain, between patients treated with defereriprone (experimental group) and untreated patients (control group). ;Primary end point(s): Variation of iron as measured by R2* (95th percentile) between the baseline MRI (performed before day 5) and the 6 month MRI, within the substantia nigra ipsilateral to stroke in the group of patients randomized to receive Deferiprone. ;Timepoint(s) of evaluation of this end point: Between baseline MRI and 6 month MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ The variation of iron as measured by R2* (95th percentile) between the baseline MRI (performed before day 5) and the 6 month MRI, within the thalamus ipsilateral to stroke (whole thalamus and median nucleus) in the group of patients randomized to receive Deferiprone. 2/ The variation of R2* and of values from quantitative susceptibility mapping (QSM) between the baseline MRI (performed before day 5) and the 6 month MRI with a voxel-by-voxel quantification in patients randomized to receive Deferiprone versus those who will not receive Deferiprone. 3/ The clinical scores at 3 months and 6 months in patients randomized to receive Deferiprone and in patients from the control group: functional outcome assessed by the upper limb Fugl-Meyer scale, the Box and Block test and the modified Rankin scale (mRS); cognitive outcome assessed by the Montreal cognitive assessment (MoCA), and mood disorders assessed by the center for epidemiologic studies depression scale (CES-D) and the generalized anxiety disorder scale (GAD-7). ;Timepoint(s) of evaluation of this end point: Baseline 3 months 6 month | — |
Countries
France
Contacts
Public ContactResponsable d'Etudes Cliniques
CHU de Bordeaux
Outcome results
None listed