Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferiprone | Experimental | Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d |
|
| Treatment As usual | Active Comparator | Patients followed during 6 months according to standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Procedure | Quantification of iron will be performed through Magnetic Resonance Imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| R2* Index within the homolateral black substance | Iron load : 95th percentile of the values of MRI R2* | Day 1 |
| R2* Index within the homolateral black substance | Iron load : 95th percentile of the values of MRI R2* | 6 Month |
| Measure | Description | Time Frame |
|---|---|---|
| R2* Index within the thalamus and the middle nucleus of the homolateral thalamus | Iron load : 95th percentile of the values of MRI R2* | Day 1 |
| R2* Index within the thalamus and the middle nucleus of the homolateral thalamus |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas TOURDIAS | University Hospital, Bordeaux | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | 33 076 | France | |||
| CHU de Lille |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Deferiprone treatment | Drug | Patients receiving Deferiprone during 6 months. Oral deferiprone for 6 months at a dose of 30 mg/kg/d |
|
Iron load : 95th percentile of the values of MRI R2*
| 6 Month |
| R2* Relaxivity values | R2* relaxivity values (95th percentile) measured on MRI | Day 1 |
| R2* Relaxivity values | R2* relaxivity values (95th percentile) measured on MRI | 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. | 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. | 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. | 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. | 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. | 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. | 6 Month |
| Modified Rankin scale Score | Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability | Day 1 |
| Modified Rankin scale Score | Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability | 3 Month |
| Modified Rankin scale Score | Disability rating scale. Score from 0 : no symptoms at all ; to 5 : severe disability | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 Month |
| Lille |
| 59000 |
| France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |