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Идёт набор NCT05324748

Repeated GON Injections in CCH

Фаза III С лечением Cluster Headache

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: Methylprednisolone, Saline solution.
Кому может быть актуально
Состояния в реестре: Cluster Headache. Базовые параметры: 18 лет — 70 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
Нидерланды
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

Repeated Corticosteroid Injections Around the Greater Occipital Nerve (GON) as Prophylactic Treatment in Chronic Cluster Headache

Обзор

Background: \- The effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. Objectives: \- The primary objective is to determine if repeated GON-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache. Eligibility: \- Patients will be selected from the LUMC (Leiden University Medical Center) and CWZ (Canisius Wilhelmina Hospital) chronic cluster headache populations, diagnosed based upon the ICHD-3. Design: \- Bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

Подробное описание

A single injection of the greater occipital nerve (GON) with corticosteroids ('GON-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. It is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. This makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. However, the effect of repeated GON-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. As such, (repeated) GON-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. The injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. It is, therefore, not known what chronic cluster headache patients can expect from this treatment.

Hypothesis: Repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.

Вмешательства

  • Препарат Methylprednisolone
    Injection with prednisolon
  • Препарат Saline solution
    0,9%

Первичные конечные точки

  • mean number of days, from first injection until discontinuation, study participants remain using study medication (retention rate in survival curve) [Срок оценки: 1 year]
Вторичные конечные точки (7)
  • Frequency of weekly cluster headache attacks vs. baseline [Срок оценки: 1 year]
  • Mean duration of attacks vs. baseline [Срок оценки: 1 year]
  • Mean severity (1-10) of attacks vs. baseline [Срок оценки: 1 year]
  • Proportion of study participants with >50% or 100% reduction in attack frequency vs. baseline [Срок оценки: 1 year]
  • Median injection interval [Срок оценки: 1 year]
  • Adverse events [Срок оценки: 1 year]
  • Ultrasound structural integrity of the greater occipital nerve [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Age ≥18 and ≤ 70 years
  • Chronic cluster headache (International Classification of Headache Disorders - third edition; ICHD-3)
  • Ictal pain must be always at the same side
  • ≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period
  • On a stable regimen of cluster headache prophylactics for >4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period

Критерии исключения

  • Contra-indication against, or current use of, corticosteroids
  • Occipital nerve stimulation (ONS)
  • Use of anticoagulation medication or a known bleeding disorder
  • Inability to use an electronic diary to monitor individual attacks and other items
  • Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache
  • Current use of prophylactic medication for other headaches
  • 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

Нидерланды · 2 центра
  • Leiden University Medical Center — Leiden
  • Canisius Wilhelmina Ziekenhuis — Nijmegen

Идентификаторы

NCT: NCT05324748 · 79665

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗