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Набор по приглашению NCT06212661

Migraine Medication Effects on Urinary Symptoms

— Наблюдательное Overactive Bladder Bladder Pain Syndrome Migraine Disorders Overactive Bladder Syndrome

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, Rimegepant, Atogepant, Eptinezumab.
Кому может быть актуально
Состояния в реестре: Overactive Bladder, Bladder Pain Syndrome, Migraine Disorders, Overactive Bladder Syndrome. Базовые параметры: от 18 лет · Женщины.
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
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Обзор

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Подробное описание

Common urinary urgency syndromes may be related to over-activation of bladder afferent pathways involving CGRP signaling. CGRP (calcitonin gene related protein) is a neurotransmitter in afferent pathways also involved in central nociception and hypersensitization. CGRP-targeted therapies, approved for migraine treatment, have the potential to alleviate lower urinary tract symptoms, but these possible effects have not been studied in humans.

This is a prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

Вмешательства

  • Препарат Ubrogepant
    Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Rimegepant
    Rimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Atogepant
    Atogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Eptinezumab
    Eptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Fremanezumab
    Fremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Galcanezumab
    Galcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Erenumab
    Erenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.
  • Препарат Botulinum toxin A
    Botolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines.

Первичные конечные точки

  • changes in OAB symptoms [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • changes in bladder pain symptoms [Срок оценки: 3 months]
  • rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine. [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Female Patients > 18 years
  • Refractory migraine, planned treatment with either:
  • CGRP inhibitors, including:
  • CGRP small molecule receptor antagonists ("gepants"): Ubrogepant, Rimegepant, Atogepant.
  • CGRP monoclonal antibodies: Eptinezumab, Fremanezumab, Galcanezumab.
  • CGRP receptor monoclonal antibodies: Erenumab.
  • BoNTA extracranial muscle injections
  • Any of the following symptoms during the last month:
  • Urinating too often (frequency).
  • Having a sudden urge to urinate that's difficult to hold back (urgency).
  • Having a sudden urge to urinate and urine leaking before you make it to the toilet (urge incontinence).

Критерии исключения

  • Age < 18 years
  • CGRP treatment within the last 12 months or BoNTA (head / bladder) last 6 months.
  • Patient (or medical decision-maker) unable to provide informed consent or unable to answer questionnaire.
  • Unable to urinate, eg: post cystectomy, indwelling catheter, on intermittent self catheterization, ESRD w/ anuria.
  • Prior bladder BoNTA in last 12 months.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Cleveland Clinic, Main Campus — Cleveland

Идентификаторы

NCT: NCT06212661 · 23-1101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗