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Идёт набор NCT05426681

Spinal Cord Injury Neuroprotection With Glyburide

Фаза I С лечением Acute Spinal Cord Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: GlyBURIDE Oral Tablet.
Кому может быть актуально
Состояния в реестре: Acute Spinal Cord Injury. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury

Обзор

To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.

Подробное описание

This study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. Subjects will begin an oral drug regimen of Glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. The daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. If indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. Participants will have labs drawn regularly, and ECGs done throughout their hospital stay. Adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.

Вмешательства

  • Препарат GlyBURIDE Oral Tablet
    Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2, and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively. Intervention: Drug: Glyburide

Первичные конечные точки

  • Rate of recruitment of patients with tSCI within the specified time window. [Срок оценки: within 8 hours of tSCI]
  • Number of drug related adverse events. [Срок оценки: One year post treatment]
Вторичные конечные точки (3)
  • Neurologic recovery following tSCI [Срок оценки: One year post enrollment.]
  • Serum Pharmacokinetics to measure Glyburide concentrations. [Срок оценки: Enrollment through post-treatment day 7.]
  • Biomarker Analysis [Срок оценки: Enrollment, Day 3, and Day 7]

Критерии участия

Критерии включения

  • No life threatening injuries resulting from the traumatic accident
  • No evidence of sepsis
  • Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
  • Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12

Критерии исключения

  • Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
  • Acute SCI with ASIA Impairment Scale grade D or E
  • Currently involved in another non-observational SCI research study or receiving another investigational drug
  • History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
  • Any condition likely to result in the patient's death within the next 12 months
  • Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2
  • Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin
  • Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
  • Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months
  • Known G6PD enzyme deficiency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Kentucky — Lexington

Идентификаторы

NCT: NCT05426681 · 77662

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗