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

Castillo, José, M.D.

Status and phase: Completed; Phase 2

Conditions: Ischemic Stroke

Treatments: Other: Solution for injection; Drug: Vitamin B2 Streuli®

Study type: Interventional

Identifiers

NCT02446977

JCS-CBG-2014-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Vitamin B2 Streuli®

Experimental group

Description:

20mg IV

Treatment:

Drug: Vitamin B2 Streuli®

Solution for injection

Placebo Comparator group

Description:

4ml IV

Treatment:

Other: Solution for injection