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Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.
The investigators hypothesis focuses on the effect of riboflavin given for the first three hours of ischemic stroke, as a reducing agent of cerebral glutamate concentration. This administration would produce a reduction of excitotoxic damage and consequently generate clinical improvement, while a lower income and a better functional outcome of patients at three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B2 Streuli® | Experimental | 20mg IV |
|
| Solution for injection | Placebo Comparator | 4ml IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B2 Streuli® | Drug | 4ml IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of serum glutamate concentration | Difference between serum glutamate concentration from basal (prior to medication infusion) and levels at 3 ± 1 and 6 ± 1 hours, from administered medication, including branch CBG000592 (riboflavin/vitamin B2) and placebo. | 7 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Days of hospitalisation | To study the average length of stay in patients with acute ischemic stroke: difference in days, between patient arrival and the patient's discharge, between the two treatment arms. | 3 months |
| Percentage of clinical improvement (basal-high) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Castillo, MD | Complejo Hospitalario Universitario de Santiago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | A Coruña | 15706 | Spain |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D007511 | Ischemia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Solution for injection | Other | 4ml IV |
|
|
To study the rate of clinical improvement in patients with acute ischemic stroke: clinical improvement according to the formula: (NIHSSbasal-NIHSSalta) / NIHSSbasal x 100 and compared between the two treatment arms. |
| 3 months |
| Functional outcome using Rankin Scale at 90 days | Study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms. | 3 months |
| Serum glutamate concentrations | Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate. | 7 hours |
| Prognosis of patients using Rankin Scale at 90 days | To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days. | 3 months |
| Number of participants with Adverse Event | Safety management: measuring adverse events throughout the study. | 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |