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

Castillo, José, M.D.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ischemic Stroke

Interventions

Vitamin B2 Streuli®DRUG

4ml IV

Solution for injectionOTHER

4ml IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Outcomes

Primary Outcomes

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.

Time frame: 7 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 3 months

Serum glutamate concentrations

Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.

Time frame: 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.

Time frame: 3 months

Number of participants with Adverse Event

Data from ClinicalTrials.gov

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