Back to resultsAdministration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Vitamin B2 Streuli®
Solution for injection
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic, stroke, vitamin B2
Eligibility 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.
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.
Sites / Locations
- Complejo Hospitalario Universitario de Santiago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin B2 Streuli®
Solution for injection
Arm Description
20mg IV
4ml IV
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Serum glutamate concentrations
Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.
Prognosis of patients using Rankin Scale at 90 days
To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.
Number of participants with Adverse Event
Safety management: measuring adverse events throughout the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02446977
Brief Title
Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Castillo, José, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic, stroke, vitamin B2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin B2 Streuli®
Arm Type
Experimental
Arm Description
20mg IV
Arm Title
Solution for injection
Arm Type
Placebo Comparator
Arm Description
4ml IV
Intervention Type
Drug
Intervention Name(s)
Vitamin B2 Streuli®
Other Intervention Name(s)
CBG000592
Intervention Description
4ml IV
Intervention Type
Other
Intervention Name(s)
Solution for injection
Other Intervention Name(s)
Placebo Comparator
Intervention Description
4ml IV
Primary Outcome Measure Information:
Title
Reduction of serum glutamate concentration
Description
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.
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Days of hospitalisation
Description
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.
Time Frame
3 months
Title
Percentage of clinical improvement (basal-high)
Description
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.
Time Frame
3 months
Title
Functional outcome using Rankin Scale at 90 days
Description
Study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms.
Time Frame
3 months
Title
Serum glutamate concentrations
Description
Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.
Time Frame
7 hours
Title
Prognosis of patients using Rankin Scale at 90 days
Description
To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.
Time Frame
3 months
Title
Number of participants with Adverse Event
Description
Safety management: measuring adverse events throughout the study.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Castillo, MD
Organizational Affiliation
Complejo Hospitalario Universitario de Santiago
Official's Role
Study Director
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke
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