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

Ischemic Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446977
• Other study ID #: JCS-CBG-2014-01
• Status: Completed
• Phase: Phase 2
• First received: April 21, 2015
• Last updated: October 12, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Castillo, José, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT02540980

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Vitamin B2 Streuli®
4ml IV

Other:
• Solution for injection
4ml IV

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Castillo, José, M.D.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of serum glutamate concentration	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.	7 hours	No
Secondary	Days of hospitalisation	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.	3 months	No
Secondary	Percentage of clinical improvement (basal-high)	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 months	No
Secondary	Functional outcome using Rankin Scale at 90 days	Study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms.	3 months	No
Secondary	Serum glutamate concentrations	Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.	7 hours	No
Secondary	Prognosis of patients using Rankin Scale at 90 days	To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.	3 months	No
Secondary	Number of participants with Adverse Event	Safety management: measuring adverse events throughout the study.	3 months	Yes