Study to see if riboflavin reduces neuronal damage in patients with acute ischemic stroke

"Randomized clinical trial with two parallel groups, double-blind, placebo-controlled trial to investigate whether administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke causes a reduction of glutamate-mediated excitotoxicity"

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003123-22-ES

Enrollment

Unknown

Registered

2014-11-05

Start date

2015-01-02

Completion date

Unknown

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Trade Name: Vitamin B2 Streuli® Pharmaceutical Form: Solution for injection INN or Proposed INN: RIBOFLAVIN SODIUM PHOSPHATE CAS Number: 130-40-5 Current Sponsor code: CBG000592 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

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, tirotricina, tetraciclines and carbomycin, at the time of inclusion.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1. Study whether patients with acute ischemic stroke and treated with CBG000592 (riboflavin) have lower average stay than those who receiving placebo. 2. Study if patients with acute ischemic stroke and were treated with CBG000592 (riboflavin) have a higher percentage of clinical improvement (basal-high) than those who receiving placebo. 3. Consider whether patients with acute ischemic stroke and treated with CBG000592 (riboflavin) have a better functional outcome than those who receiving placebo. 4. Investigate the variations of serum glutamate levels among acute ischemic stroke patients treated with CBG000592 (riboflavin) or placebo. 5. Explore whether the prognosis of patients receiving CBG00592 (riboflavin) and have no stroke is not worse than those treated with placebo. 6. Assess if CBG000592 (riboflavin) administration in patients with clinical suspicion of stroke, administered within the first three hours of onset is safe.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Baseline (before drug administration) and at 3±1 and at 6±1 hours;Main Objective: Assess whether CBG000592 (riboflavin/vitamin B2) administration in patients with acute ischemic stroke induces a reduction of serum glutamate concentration.	—

Measure

Time frame

Secondary Objective: 1. Study whether patients with acute ischemic stroke and treated with CBG000592 (riboflavin) have lower average stay than those who receiving placebo. 2. Study if patients with acute ischemic stroke and were treated with CBG000592 (riboflavin) have a higher percentage of clinical improvement (basal-high) than those who receiving placebo. 3. Consider whether patients with acute ischemic stroke and treated with CBG000592 (riboflavin) have a better functional outcome than those who receiving placebo. 4. Investigate the variations of serum glutamate levels among acute ischemic stroke patients treated with CBG000592 (riboflavin) or placebo. 5. Explore whether the prognosis of patients receiving CBG00592 (riboflavin) and have no stroke is not worse than those treated with placebo. 6. Assess if CBG000592 (riboflavin) administration in patients with clinical suspicion of stroke, administered within the first three hours of onset is safe.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Baseline (before drug administration) and at 3±1 and at 6±1 hours;Main Objective: Assess whether CBG000592 (riboflavin/vitamin B2) administration in patients with acute ischemic stroke induces a reduction of serum glutamate concentration.

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Secondary

Measure	Time frame
Secondary end point(s): - 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. - 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. - To study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms. - Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate. - To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days. - Safety management: measuring adverse events throughout the study.;Timepoint(s) of evaluation of this end point: - Aaverage 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. - Rate of clinical improvement in patients with acute ischemic stroke: clinical improvement according to the formula: (NIHSSbasal-NIHSSdischarge) / NIHSSbasal x 100 and compared between the two treatment arms. - Functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms. - Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate. - Prognosis of patients without stroke: modified Rankin scale at 90 days. - Safety management: measuring adverse events throughout the study.	—

Measure

Time frame

Secondary end point(s): - 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. - 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. - To study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms. - Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate. - To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days. - Safety management: measuring adverse events throughout the study.;Timepoint(s) of evaluation of this end point: - Aaverage 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. - Rate of clinical improvement in patients with acute ischemic stroke: clinical improvement according to the formula: (NIHSSbasal-NIHSSdischarge) / NIHSSbasal x 100 and compared between the two treatment arms. - Functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms. - Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate. - Prognosis of patients without stroke: modified Rankin scale at 90 days. - Safety management: measuring adverse events throughout the study.

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Countries

Spain

Contacts

Public ContactFundación Ramón Domínguez

Fundación Ramón Domínguez

caiber.chus@sergas.es+34981955041

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026