2024-514230-20-00CompletedPhase 2
Long-term iron chelation in the prevention of secondary remote degeneration after stroke
Centre Hospitalier Universitaire De Bordeaux4 sites in 1 country100 target enrollmentStarted: August 20, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
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 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
- •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
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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
- 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
- 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 (CESD) and the generalized anxiety disorder scale (GAD-7)
Investigators
Co-ordinating Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
Study Sites (4)
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