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Completed

NCT Number: NCT02446977

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

Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin B2 Streuli®

Drug

4ml IV

Other names: CBG000592

Solution for injection

Other

4ml IV

Other names: Placebo Comparator

Primary outcomes

  1. Reduction of serum glutamate concentration

    Time frame: 7 hours

    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.

Secondary outcomes

  1. Days of hospitalisation

    Time frame: 3 months

    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.

  2. Percentage of clinical improvement (basal-high)

    Time frame: 3 months

    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. Functional outcome using Rankin Scale at 90 days

    Time frame: 3 months

    Study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms.

  4. Serum glutamate concentrations

    Time frame: 7 hours

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

  5. Prognosis of patients using Rankin Scale at 90 days

    Time frame: 3 months

    To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.

  6. Number of participants with Adverse Event

    Time frame: 3 months

    Safety management: measuring adverse events throughout the study.

Sponsors and collaborators

Lead sponsor

Castillo, José, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 18, 2015
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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