Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke

Completed

Phase 2 Results N/A

Update History

1 Mar '16
The Summary of Purpose was updated.
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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.
Old
Our hypothesis focuses on the effect of riboflavin administered during 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 prognosis of patients at three months.
The description was updated.
New
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.
Old
It is a national, single-center, parallel, randomized, double-blind, placebo-controlled study to evaluate whether the administration IV only 20 mg (bolus) of riboflavin to patients with acute ischemic stroke within three hours of evolution produces a variation serum glutamate. Patients will be assigned to one of two treatment groups, as shown below: or Arm A (control): single administration of placebo (saline solution) IV bolus. or Arm B (experimental): single IV administration of CBG000592 (riboflavin) bolus. All selected patients will be randomized to one of the two arms of the study, the control group (Arm A) or the experimental (Arm B) in a ratio of 1: 1. The allocation to either treatment will take place through a computerized randomization. The participation of each patient in the study will take approximately three months. The duration of the recruitment period is six months, then patients will be followed for three months. The primary endpoint in this study is the measurement of the concentration of serum glutamate. Patients will be evaluated in relation to length of stay, percentage of clinical improvement and functional prognosis. Patients end their participation in the study once they have completed all the procedures, or by a decision of the investigator or whether revoke their consent. The study end date is the last visit of the last patient in the center, this is expected to take place in October 2015
The eligibility criteria were updated.
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Inclusion Criteria: 1. Patients older than 18 years, both men and women. 2. Patient or legal representative able to understand and sign the informed consent. 3. Patients with suspected stroke within 3 hours of onset. Exclusion Criteria: 1. Women of childbearing age, with potential for pregnancy or breastfeeding. 2. Patients with a score ≥ 2 point 1a in the NIHSS scale. 3. Scale pre-stroke modified Rankin ≥ 2. 4. Inability to prior testing image needed for the study. 5. Previous disorders that may interfere with the interpretation of neurological scales. 6. Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tyrothricin, tetracyclines and carbomycin, at the time of inclusion.
Old
Inclusion Criteria: 1. Patients older than 18 years, both men and women. 2. Patient or legal representative able to understand and sign the informed consent. 3. Patients with suspected stroke within 3 hours of onset. Exclusion Criteria: 1. Women of childbearing age, with potential for pregnancy or breastfeeding. 2. Patients with a score ? 2 point 1a in the NIHSS scale. 3. Scale pre-stroke modified Rankin ? 2. 4. Inability to prior testing image needed for the study. 5. Previous disorders that may interfere with the interpretation of neurological scales. 6. Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tyrothricin, tetracyclines and carbomycin, at the time of inclusion.
A location was updated in Santiago de Compostela.
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The overall status was removed for Complejo Hospitalario Universitario de Santiago.