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Идёт набор NCT04121468

A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis

Фаза I / Фаза II С лечением Multiple Sclerosis (MS)

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: Metformin, Placebo.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis (MS). Базовые параметры: 10 лет — 25 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
Канада
Следующий шаг
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Обзор

A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.

Вмешательства

  • Препарат Metformin
    Each tablet contains 500mg of metformin hydrochloride
  • Другое Placebo
    Each tablet contains no active drug ingredient

Первичные конечные точки

  • Number of patients with adverse events (safety and tolerability) [Срок оценки: 3 years]
  • Number of patients who were approached to participate, declined participation and consented to participate (recruitment) [Срок оценки: 3 years]
  • Proportion of patients who completed each visit within the trial (retention) [Срок оценки: 3 years]
  • Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures) [Срок оценки: 3 years]
  • Number of patients enrolled in the study compared to the number of patients who were able to complete study measures (tolerability with outcome measures) [Срок оценки: 3 years]
Вторичные конечные точки (4)
  • Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness [Срок оценки: 3 years]
  • Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness [Срок оценки: 3 years]
  • Optical Coherence Tomography (OCT) - Optic Nerve Head Volume [Срок оценки: 3 years]
  • Visual Evoked Potentials (VEP) - p100 [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Patients with a history of MS with anterior visual pathway involvement and longer than 6 months after presentation with ON or an acute demyelinating event/relapse
  • Age 10 year to 25 years and 11 months
  • Latency delay > 115 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination) or > 10 milliseconds difference between eyes, or Retinal Nerve Fiber Layer (RNFL) thickness on OCT of < 90 µm in at least one eye or an inter-eye difference in the RNFL of 10 µm or more
  • Retinal Nerve Fiber Layer (RNFL) Thickness on baseline OCT ≥60 µm
  • If on an MS disease-modifying therapy, no changes in the therapeutic agent or dosing in the 6 months prior to study initiation
  • No significant renal or liver abnormalities
  • Expanded Disability Status Scale (EDSS) 0-6.0 (inclusive)
  • Has either English as his or her native language or English comprehension needed to complete the neuropsychological testing
  • Meet criteria for adequate organ function requirements as described below:

Adequate renal function defined as:

Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 70 mL/min/1.73 m2 or serum creatinine based on age/gender as follows:

Range Serum Creatinine Level (µmol/L): Age 5 to <12 years (male)=25-50, Age 5 to <12 years (female)=25-50; Age 12 to <15 years (male)=37-67, Age 12 to <15 years (female)=37-67; Age 15 to <19 years (male)=51-89, Age 15 to <19 years (female)=40-69; Age ≥19 years (male)=58-110; Age ≥19 years (female)=46-92

Adequate liver function defined as:

Total bilirubin < 1.5 x upper limit of normal (ULN) for age SGOT (AST) or SGPT (ALT) < 1.5 x upper limit of normal (ULN) for age

Критерии исключения

  • A history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders)
  • Unstable and/or insulin-dependent (Type 1) diabetes, metabolic acidosis and/or lactic acidosis
  • History of unexplained hypoglycemia (<2.8 mmol/L)
  • Already on metformin
  • Concomitant use of any other putative remyelinating therapy as determined by the Principal/Qualified Investigator
  • Treatment for an acute attack with corticosteroids within 30 days prior to screening / relapse within 30 days prior to screening
  • Concomitant use of insulin
  • Concomitant use of any drugs that are listed to have drug-drug interactions with metformin (i.e. calcium channel blockers, diuretics, etc.) as determined by Principal/Qualified Investigator
  • Lactate levels > 1.5x upper limit of normal
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT04121468 · 1000059119

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗