Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

Обзор

Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.

Вмешательства

• Препарат Rimegepant 75 MG
  The interventional product is rimegepant ODT 75 mg. Rimegepant 75mg ODT will be given 2 hours prior to a trigger exposure for exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours rimegepant will be dosed 2 hours prior to trigger exposure. For weekend or let down headache and changes in sleep pattern, rimegepant will be dosed the night before. The m

Первичные конечные точки

• Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity [Срок оценки: 24 hour post dose]

Вторичные конечные точки (3)

• Percentage of preemptive treatments with rimegepant [Срок оценки: 24 hour, 48 hour post dose]
• Patient satisfaction with preemptive treatment with rimegepant [Срок оценки: At the end of the study completion( 2 month after enrollment)]
• The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC) [Срок оценки: At the end of study completion( 2 months after enrollement)]

Критерии участия

Критерии включения

• Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)
• Men and women ≥ 18 years old .
• Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
• Headache/migraine onset before age 50 years
• Migraine attacks, on average, lasting 4-72 hours if untreated
• At least 48 hours between migraine attacks
• Ability to distinguish migraine attacks from tension or cluster headaches
• Particpants on SOC treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the course of the study
• Participant may have been on treatment with Botox or mAbs for the last 6 months
• Participants experience migraine ≥75% of the time following exposure to a trigger during the run-in period. Acceptable triggers include exercise, alcohol ( less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or weekend/ let-down

Критерии исключения

• Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment
• History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening
• Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.
• Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
• Women must not be pregnant, lactating or breastfeeding

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

Профилактика

Центры проведения

США · 1 центр

• MedStar Health: Neurology at McLean — McLean

Идентификаторы

NCT: NCT07301008 · STUDY00008797

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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