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Идёт набор NCT06863740

Using Cannabis to Treat Restless Legs Syndrome

Без фазы С лечением Restless Leg Syndrome (RLS)

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: Cannabis oil, Cannabis placebo.
Кому может быть актуально
Состояния в реестре: Restless Leg Syndrome (RLS). Базовые параметры: от 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Using Cannabis to Treat Restless Legs Syndrome: A Randomized Placebo Controlled Pilot Safety and Feasibility Trial

Обзор

Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.

Вмешательства

  • Препарат Cannabis oil
    5:1 CBD:THC oral formulation with a concentration of 25 mg/g CBD and 5 mg/g THC in a pharmaceutical grade medium chain triglyceride (MCT) oil.
  • Препарат Cannabis placebo
    Placebo oil

Первичные конечные точки

  • Incidence of Adverse Events and Serious Adverse Events [Срок оценки: 8 weeks]
  • Rate of Study Completion [Срок оценки: 8 weeks]
Вторичные конечные точки (9)
  • Change from Baseline in Restless Legs Syndrome Quality of Life (RLSQoL) at 8 Weeks [Срок оценки: 8 weeks]
  • Change from Baseline in Self-Reported Quality of Life on the Short Form-36 (SF-36) Health Survey Questionnaire at 8 Weeks [Срок оценки: 8 weeks]
  • Change in Restless Legs Syndrome Severity using the International RLS Study Group Rating Scale from Baseline to Follow-up [Срок оценки: 8 weeks]
  • Change in Sleep Quality as assessed by the Pittsburgh Sleep Quality Index from Baseline to Follow-Up [Срок оценки: 8 weeks]
  • Change in Daytime Sleepiness as assessed by the Epworth Sleepiness Scale from Baseline to Follow-Up [Срок оценки: 8 weeks]
  • Change in Mood as assessed by the Beck Depression Inventory from Baseline to Follow-Up [Срок оценки: 8 weeks]
  • Change in Objective Sleep Quality as Measured by Actigraphy from Baseline to Follow-Up [Срок оценки: 8 weeks]
  • Change in Leg Movements as Measured by Ankle Actigraphy from Baseline to Follow-Up [Срок оценки: 8 weeks]
  • Change in Obstructive Sleep Apnea (OSA) Severity (as measured by the apnea-hypopnea index) from Baseline to Follow-Up [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • ≥25 years of age
  • diagnosis of RLS based on the International RLS Study Group criteria
  • refractory RLS symptoms despite use of dopaminergic and/or alpha-2-delta ligand therapy
  • onset of RLS at least 6 months before screening

Критерии исключения

  • sleep disordered breathing, or sleep disordered breathing that is not adequately controlled on therapy (apnea-hypopnea index of >15)
  • cannabis use within 4 weeks of study enrollment
  • known allergy to cannabis, cannabinoids or palm/coconut oil
  • Currently pregnant or breast-feeding (a negative urine pregnancy test must be obtained for women of childbearing potential during pretreatment evaluation)
  • Active substance abuse
  • Ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension
  • Serious liver disease
  • History of schizophrenia or any other psychotic disorder

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 · 2 центра
  • Sunnybrook Health Sciences Centre — Toronto
  • University Health Network — Toronto

Идентификаторы

NCT: NCT06863740 · 4752

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗