Ischemic StrokePhase 2NCT02446977
Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke
A Phase 2 study testing Vitamin B2 Streuli® and Solution for injection in people with Ischemic Stroke, run by Castillo, José, M.D. at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Vitamin B2 Streuli® and Solution for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
About this study
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
Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Vitamin B2 Streuli®, Solution for injection
- Keywords
- ischemic, stroke, vitamin B2
- Medical subject headings
- Ischemic Stroke, Ischemia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B2 Streuli®Drug
Also called CBG000592
4ml IV
Solution for injectionOther
Also called Placebo Comparator
4ml IV
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B2 Streuli® | Experimental | 20mg IV Receives: Drug: Vitamin B2 Streuli® |
| Solution for injection | Placebo comparator | 4ml IV Receives: Other: Solution for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 hours
Secondary outcomes (6)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Serum glutamate concentrations
Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.
Measured: 7 hours
Prognosis of patients using Rankin Scale at 90 days
To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.
Measured: 3 months
Number of participants with Adverse Event
Safety management: measuring adverse events throughout the study.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castillo, José, M.D.
- Responsible party
- Sponsor
- Investigators
- José Castillo, MD, Study director, Complejo Hospitalario Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446977
- Sponsor's protocol ID
- JCS-CBG-2014-01
- Status last verified
- Oct 2016
- First submitted
- 21 Apr 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02446977
- Acronym / sponsor ID
- JCS-CBG-2014-01
- Conditions
- Ischemic Stroke
- Keywords
- ischemic, stroke, vitamin B2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Castillo, José, M.D.
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B2 Streuli® | Experimental | Drug: Vitamin B2 Streuli®20mg IV |
| Solution for injection | Placebo comparator | Other: Solution for injection4ml IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin B2 Streuli®Also: CBG0005924ml IV | Drug | Vitamin B2 Streuli® |
| Solution for injectionAlso: Placebo Comparator4ml IV | Other | Solution for injection |
Primary outcome
Reduction of serum glutamate concentration
Time frame: 7 hours
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.
6 secondary outcomes
Days of hospitalisation
Time frame: 3 months
Percentage of clinical improvement (basal-high)
Time frame: 3 months
Functional outcome using Rankin Scale at 90 days
Time frame: 3 months
Serum glutamate concentrations
Time frame: 7 hours
Prognosis of patients using Rankin Scale at 90 days
Time frame: 3 months
Number of participants with Adverse Event
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Castillo, MD study director
Complejo Hospitalario Universitario de Santiago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin B2 Streuli® and Solution for injection in people with Ischemic Stroke, run by Castillo, José, M.D. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of serum glutamate concentration (time frame: 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.