Идёт набор NCT07018713
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
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: Xeomin, Placebo.
- Кому может быть актуально
- Состояния в реестре: Chronic 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, Австрия, Канада, Чехия, Дания +8
- 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 Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Chronic Migraine
Обзор
In this clinical trial, participants with chronic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: * Trial duration: 52 to 55 weeks; * Screening period: 4 to 5 weeks; * Treatment duration: 4 treatments, each about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.
Вмешательства
- Препарат Xeomin
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) - Препарат Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Первичные конечные точки
- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [Срок оценки: Baseline to month 6]
Вторичные конечные точки (8)
- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B [Срок оценки: Baseline to month 6]
- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [Срок оценки: Baseline to month 6]
- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B [Срок оценки: Baseline to month 6]
- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [Срок оценки: Baseline to month 6]
- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B [Срок оценки: Baseline to month 6]
- Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4) [Срок оценки: Baseline up to month 11]
- Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) [Срок оценки: Baseline to month 6]
- Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period [Срок оценки: Month 6]
Критерии участия
Критерии включения
- Participant has a diagnosis of CM with or without aura according to the International Classification of Headache Disorders Edition 3 criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;
- Participant age < 50 years at the time of migraine onset;
- Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≥ 15 headache days per month and history of ≥ 8 migraine days per month; and
- During the last 28 days of the screening period, participant experiencing: ≥ 15 headache days and ≥ 8 migraine days that qualify as such per the headache diary.
Критерии исключения
- Diagnosis of other primary headache types, except tension-type headache, which is permitted;
- Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction;
- Diagnosis of secondary headache types, except medication overuse headache, which is permitted;
- Currently taking > 1 prescribed drug for the preventive treatment of migraine;
- Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 47 центров
- TrialSphere Corp, Merz Investigational Site #0010513 — Chandler
- Arizona Neuroscience Research, Merz Investigational Site #0010521 — Phoenix
- Baptist Health Medical Center, Merz Investigational Site #0010520 — Little Rock
- Chemidox Clinical Trials Inc, Merz Investigational Site #0010488 — Lancaster
- Clinical Research Institute, Merz Investigational Site #0010487 — Los Angeles
- BNL Health, Merz Investigational Site #0010501 — Los Angeles
- Clinical Trials Management Services, Merz Investigational Site #0010526 — Thousand Oaks
- Hasbani Neurology, Merz Investigational Site #0010509 — New Haven
- … и ещё 39 центров
Польша · 19 центров
- Centrum Medyczne Neuromed, Merz Investigational Site #0480117 — Bydgoszcz
- AthleticoMed, Merz Investigational Site #0480127 — Bydgoszcz
- ETG Debica, Merz Investigational Site #0480121 — Dębica
- Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126 — Gdynia
- Silmedic Sp. z o.o., Merz Investigational Site #0480115 — Katowice
- Jan Banach Research Spot, Merz Investigational Site #0480059 — Krakow
- Pratia MCM, Merz Investigational Site #0480087 — Krakow
- FutureMeds, Merz Investigational Site #0480125 — Krakow
- … и ещё 11 центров
Испания · 13 центров
Список центров уточняется — проверьте первичный протокол.
Чехия · 5 центров
- Pratia Brno, Merz Investigational Site #4200053 — Brno
- Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056 — Hradec Králové
- CLINTRIAL, Merz Investigational Site #4200052 — Prague
- Axon Clinical, Merz Investigational Site #4200051 — Prague
- Neuropsychiatrie, Merz Investigational Site #4200054 — Prague
Германия · 5 центров
- Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398 — Berlin
- Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394 — Frankfurt
- Universitätsmedizin Greifswald, Merz Investigational Site #0490397 — Greifswald
- Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396 — Kassel
- Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395 — Kiel
Италия · 5 центров
- Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023 — Florence
- Ospedale San Raffaele, Merz Investigational Site #0390027 — Milan
- Istituto Auxologico Italiano, Merz Investigational Site #0390024 — Milan
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #039 — Pavia
- IRCCS San Raffaele Roma, Merz Investigational Site #0390026 — Roma
Словакия · 4 центра
Список центров уточняется — проверьте первичный протокол.
Франция · 3 центра
- CHU Clermont Ferrand, Merz Investigational Site #0330026 — Clermont-Ferrand
- Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069 — La Tronche
- CHU Nantes, Merz Investigational Site #0330068 — Nantes
Австрия · 2 центра
- Medical University of Innsbruck, Merz Investigational Site #0430043 — Innsbruck
- Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042 — Klagenfurt
Канада · 2 центра
- Genge Partners Inc., Merz Investigational Site #0010525 — Montreal
- CaRe Clinic, Merz Investigational Site #0010504 — Red Deer
Швейцария · 2 центра
Список центров уточняется — проверьте первичный протокол.
Дания · 1 центр
- Rigshospitalet-Glostrup, Merz Investigational Site #0450006 — Glostrup Municipality
Великобритания · 1 центр
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07018713 · M602011084 · 2024-515682-34-00