Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
NCT Number: NCT02446977
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Santiago de Compostela, A Coruña, 15706, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4ml IV
Other names: CBG000592
4ml IV
Other names: Placebo Comparator
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.
Time frame: 3 months
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
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
Study the functional outcome in patients with acute ischemic stroke: modified Rankin scale at 90 days, between two treatment arms.
Time frame: 7 hours
Variations of serum glutamate curves in patients with acute ischemic stroke between two branches: all concentrations of serum glutamate.
Time frame: 3 months
To explore the prognosis of patients without stroke, evaluating modified Rankin scale at 90 days.
Time frame: 3 months
Safety management: measuring adverse events throughout the study.
Castillo, José, M.D.
Indiv
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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