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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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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

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin B2 Streuli®

20mg IV

Group Type EXPERIMENTAL

Vitamin B2 Streuli®

Intervention Type DRUG

4ml IV

Solution for injection

4ml IV

Group Type PLACEBO_COMPARATOR

Solution for injection

Intervention Type OTHER

4ml IV

Interventions

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Vitamin B2 Streuli®

4ml IV

Intervention Type DRUG

Solution for injection

4ml IV

Intervention Type OTHER

Other Intervention Names

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CBG000592 Placebo Comparator

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No