Trial | NCT02446977  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    riboflavin ...

  • Study Participants

    50
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 Started
Mar 31
2015
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Oct 13
2016
Estimate

Drug Vitamin B2 Streuli®

4ml IV

  • Other names: CBG000592

Other Solution for injection

4ml IV

  • Other names: Placebo Comparator

Vitamin B2 Streuli® Experimental

20mg IV

Solution for injection Placebo Comparator

4ml IV

Criteria 

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.
No Results Posted