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

Completed

Phase 2 Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 4ml once
    ARM 1: Kind: Experimental
    Label: Solution for injection
    Description: 4 ml once in emergency room
  • Vitamin B2 Streuli® Drug
    Other Names: CBG000592
    Intervention Desc: 4ml IV
    ARM 1: Kind: Experimental
    Label: Vitamin B2 Streuli®
    Description: 20mg IV once in the emergency room
  • Solution for injection Other
    Other Names: Placebo Comparator
    Intervention Desc: 4ml IV
    ARM 1: Kind: Experimental
    Label: Solution for injection
    Description: 4ml IV

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduction of serum glutamate concentration. 7 hours No
Secondary Reduction of hospitalization in patients treated with CBG000592 (riboflavin) 3 months No
Secondary Percentage of clinical improvement (basal-high) in patients treated with CBG000592. 3 months No
Secondary Better functional outcome in patients treated with CBG000592. 3 months No
Secondary Variations of serum glutamate levels among acute ischemic stroke patients treated with CBG000592 (riboflavin) or placebo. 7 hours No
Secondary Prognosis of patients receiving CBG00592 (riboflavin) 3 months No
Secondary Safety of CBG000592 (riboflavin) (adverse events) 3 months Yes
Primary Reduction of serum glutamate concentration 7 hours No
Secondary Days of hospitalisation 3 months No
Secondary Percentage of clinical improvement (basal-high) 3 months No
Secondary Functional outcome using Rankin Scale at 90 days 3 months No
Secondary Serum glutamate concentrations 7 hours No
Secondary Prognosis of patients using Rankin Scale at 90 days 3 months No
Secondary Number of participants with Adverse Event 3 months Yes

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