Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications
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: Zavegepant.
- Кому может быть актуально
- Состояния в реестре: Migraine. Базовые параметры: от 18 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
A Study to Assess Effectiveness and Tolerability of Zavegepant as an Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications.
Обзор
Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.
Подробное описание
This is a phase IV, open-label, prospective, longitudinal clinical trial of intranasal zavegepant 10 mg, a CGRP receptor antagonist, for the acute treatment of migraine attacks amongst individuals who are concomitantly taking stable doses of CGRP targeting migraine preventive treatment (atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant). The effectiveness and tolerability of zavegepant will be assessed in this specific participant population. Participants who are not already taking a CGRP-targeting migraine preventive treatment but who meet criteria for migraine prevention according to their clinician's discretion, will have the option to start rimegepant 75 mg every other day (qod) for two months. After two months, continued eligibility for participation in the clinical trial of zavegepant will be assessed. Those receiving rimegepant for migraine prevention through their participation in this study will have the option to receive rimegepant for up to 32 consecutive weeks.
Вмешательства
- Препарат Zavegepant
10 mg intranasal
Первичные конечные точки
- Headache relief in 2 hours [Срок оценки: 2 hours]
- Headache relief in 4 hours [Срок оценки: 4 hours]
- Functional disability level in 2 hours [Срок оценки: 2 hours]
- Functional disability level in 4 hours [Срок оценки: 4 hours]
Вторичные конечные точки (3)
- Adverse events [Срок оценки: Approximately 24-32 weeks]
- Serious adverse events [Срок оценки: Approximately 24-32 weeks]
- Discontinuation due to adverse events [Срок оценки: Approximately 24-32 weeks]
Критерии участия
Критерии включения
- Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura
- At least 18 years of age
- 2- 8 migraine attacks per month
- Participants should be on a calcitonin gene-related peptide (CGRP)-targeting preventive migraine medication on a stable dose for a) ≥2 months prior to zavegepant treatment if an oral gepant or a monoclonal antibody (mAb) injected monthly, or b) at least two treatments if a mAb injected each 3 months.
- Atogepant
- Eptinezumab
- Erenumab
- Fremanezumab
- Galcanezumab
- Rimegepant
Критерии исключения
- Primary headache disorders other than migraine (tension-type headache days are allowed)
- History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant
Eligibility Notes
- Participants may have either episodic or chronic migraine.
- Prior use of zavegepant and other gepants is permitted.
- Participants can be using migraine preventive medications/treatments in addition to the CGRP-targeting preventive treatment, as long as those treatments have been stable for at least two months at the time of enrollment.
Additional Eligibility Criteria for Participants to Start on Rimegepant for Migraine Prevention
Критерии включения
- Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report.
Критерии исключения
- History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Mayo Clinic in Arizona — Phoenix
Идентификаторы
NCT: NCT06401642 · 23-011210