Migraine Medication Effects on Urinary Symptoms

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06212661
Status
Enrolling By Invitation

Conditions

  • Bladder Pain Syndrome
  • Interstitial Cystitis
  • Migraine
  • Migraine Disorders
  • Overactive Bladder
  • Overactive Bladder Syndrome
  • Overactive Detrusor

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 5, 2024
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: CGRP inhibitor
    * Ubrogepant (Ubrelvy™) * Rimegepant (Nurtec®) * Atogepant (Qulipta™) * Eptinezumab (Vyepti®) * Fremanezumab (Ajovy®) * Galcanezumab (Emgality®) * Erenumab (Aimovig®) dosage and duration according to provider's clinical decision.
  • Arm: BoNTA extracranial muscle injections
    Botolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision

Primary Outcome Measure

changes in OAB symptoms [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Main CampusClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Migraine
By specialty
Neurology
By research site
Cleveland Clinic, Main Campus· Cleveland, OH

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