Study on Deferiprone for Preventing Secondary Degeneration in Stroke Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Deferiprone, which is marketed under the name Ferriprox, in patients who have experienced a stroke. A stroke occurs when blood flow to a part of the brain is interrupted, leading to potential damage. The purpose of this study is to explore whether taking Deferiprone can help prevent further damage in the brain after a stroke by reducing iron accumulation, which can be harmful.

Participants in the study will take Deferiprone in the form of film-coated tablets. The treatment will be administered daily at a low dose for a period of six months. The study will compare the effects of this treatment on iron levels in the brain with those observed in previous research where no treatment was given. The study will involve taking MRI scans, which are imaging tests that help visualize the brain, at the beginning and end of the six-month period to assess changes in iron levels.

Throughout the study, participants will be monitored for any changes in their condition, including their physical and cognitive abilities, as well as their mood. These assessments will help determine the overall impact of Deferiprone on recovery after a stroke. The study aims to provide valuable insights into whether this medication can be beneficial in preventing further brain damage following a stroke.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written consent is required before any trial-related activities begin. If the patient is unable to provide consent due to medical conditions, a trusted person may provide consent on their behalf.

2 initial assessment

An initial MRI scan will be conducted before day 5 to assess iron levels in the brain. This scan serves as a baseline for future comparisons.

3 medication administration

The patient will begin taking Ferriprox (deferiprone) 500 mg film-coated tablets. The medication is administered orally at a low dose of 30 mg per kilogram of body weight per day. Treatment starts between day 3 and day 5 after the initial assessment and continues for 6 months.

4 ongoing monitoring

Throughout the 6-month treatment period, the patient will be monitored regularly. This includes clinical assessments and additional MRI scans to track changes in iron levels and evaluate the treatment’s effectiveness.

5 midpoint evaluation

At 3 months, the patient will undergo clinical evaluations to assess functional and cognitive outcomes. These assessments include tests for upper limb function, cognitive abilities, and mood.

6 final assessment

At the end of the 6-month period, a final MRI scan will be performed to measure iron levels in the brain. Clinical evaluations will also be conducted to assess the patient’s overall progress and outcomes.

Who Can Join the Study?

Patient must be older than 18 years old.
Patient must have social insurance coverage.
Patient must have had a stroke affecting a specific area of the brain called the middle cerebral artery, which includes at least half of a part of the brain known as the striatum. This can happen if a main artery is blocked or has been unblocked but still affects the striatum.
Patient must have a certain level of neutrophils, which are a type of white blood cell important for fighting infections. The count should be at least 1.5 x 10⁹/L.
Women who can have children must have a negative pregnancy test and use effective birth control methods, such as birth control pills, an intra-uterine device, or have had a procedure like bilateral salpingectomy (removal of both fallopian tubes). This should continue for 6 months after the last dose of the study medication.
Men must ensure their partner uses effective birth control or agree to use a condom during the study and for 90 days after the last dose of the study medication.
Patient must provide written informed consent before starting any study-related procedures. If a patient cannot give consent due to severe communication issues or understanding problems caused by the stroke, a trusted person, family member, or someone close to the patient can give consent on their behalf. The patient will be informed as soon as possible and asked for their consent if they regain the ability to do so during follow-up visits.

Who Cannot Join the Study?

Patients who have had a stroke cannot participate. A stroke is when blood flow to a part of the brain is stopped, causing brain cells to die.
Patients with a proximal occlusion of the sylvian artery are excluded. This means there is a blockage in a major blood vessel in the brain.
Patients who cannot undergo an MRI are excluded. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
Patients who are not within the specified age range are excluded. The trial is for certain age groups only.
Patients who are not able to take the medication deferiprone (Ferriprox®) are excluded. This is a drug used to reduce iron levels in the body.
Patients who are part of a vulnerable population are excluded. This refers to groups of people who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.06.2022

Trial locations

Investigated drugs:

Deferiprone

Ferriprox: This medication is used in the trial to help prevent damage that can occur after a stroke. It works by reducing the amount of iron in the body, which can be harmful if it builds up too much. In this study, patients take Ferriprox daily for six months to see if it can help reduce iron accumulation in the brain after a stroke.

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can lead to brain cells beginning to die within minutes. There are two main types of stroke: ischemic, caused by a blockage in an artery, and hemorrhagic, caused by a blood vessel leaking or bursting. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of a stroke can lead to significant neurological damage if not addressed quickly. Recovery and progression vary widely depending on the severity and location of the stroke.

Trial ID:

2024-514230-20-00

Protocol code:

CHUBX 2019/49

NCT ID:

NCT05111821

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Deferiprone for Preventing Secondary Degeneration in Stroke Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?