Набор по приглашению NCT05127954

Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)

Фаза III С лечением 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: Ubrogepant.
Кому может быть актуально: Состояния в реестре: Migraine. Базовые параметры: 6 лет — 17 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, Пуэрто-Рико
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 Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)

Обзор

Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate long term safety and tolerability of ubrogepant in the acute treatment of migraine in pediatric participants. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Pediatric participants (aged 6-17 years) with a history of migraine will be enrolled. Participants who completed the lead-in Study 3110-305-002, as well as those who were placebo responders and screen failed, will be eligible to enroll into this study. Around 1200 participants will be enrolled in the study at approximately 120 sites in the United States. Participants may receive ubrogepant oral tables to treat up to 8 migraine attacks of any intensity per month. There will be an option to take a second dose of study intervention (identical to initial dose), or rescue medication, starting 2 hours after the initial dose. The study duration will be up to 54 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Вмешательства

Препарат Ubrogepant
Oral Tablet

Первичные конечные точки

Percentage of Participants with Adverse Events (AEs) [Срок оценки: up to 54 weeks]
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG) [Срок оценки: Up to 54 Weeks]
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters [Срок оценки: Up to 54 Weeks]
Percentage of Participants with Potentially Clinically Significant lab values [Срок оценки: Up to 54 Weeks]
Percentage of with Participants with Suicidal Ideation or Suicidal Behavior [Срок оценки: Up to 54 Weeks]
Percentage of Participants with Change in Menstrual Cycle [Срок оценки: Up to 54 Weeks]
Change from baseline in Tanner staging score [Срок оценки: Up to 54 Weeks]
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire [Срок оценки: up to 54 weeks]

Критерии участия

Критерии включения

Completers of the lead-in Study 3110-305-002 (in the main study or PK cohort) or those who screen failed due to being placebo responders.
Demonstrated an acceptable degree of compliance with study procedures in the lead-in study and who, in the investigator's clinical judgment, did not experience an AE that may indicate an unacceptable safety risk for this study.

Критерии исключения

Requirement for any medication (eg, barbiturates) or diet (eg, grapefruit juice) that is on the list of prohibited concomitant medications that cannot be discontinued or switched to an allowable, alternative medication at Visit 1.
An ECG with clinically significant abnormalities at Visit 1 as determined by the investigator.
Clinically significant abnormalities in physical examination at Visit 1, as determined by the investigator.
Significant risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; participants should be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS), or report suicidal behavior at Visit 1
Any medical or other reason (eg, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study) that, in the investigator's opinion, might indicate that the participant is unsuitable for the study.

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

Здоровые добровольцы: Нет