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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial to Investigate Whether Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke Causes a Reduction of Glutamate-mediated Excitotoxicity

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Vitamin B2 Streuli®
* Other: Solution for injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years, both men and women. Patient or legal representative able to understand and sign the informed consent. Patients with suspected stroke within 3 hours of onset. Exclusion Criteria: Women of childbearing age, with potential for pregnancy or breastfeeding. Patients with a score ≥ 2 point 1a in the NIHSS scale. Scale pre-stroke modified Rankin ≥ 2. Inability to prior testing image needed for the study. Previous disorders that may interfere with the interpretation of neurological scales. Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tyrothricin, tetracyclines and carbomycin, at the time of inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin B2 Streuli®<br>20mg IV | Drug: Vitamin B2 Streuli®<br>* 4ml IV<br>* Other names: CBG000592;|
| Placebo Comparator: Solution for injection<br>4ml IV | Other: Solution for injection<br>* 4ml IV<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic, stroke, vitamin B2