NCT06212661

Migraine Medication Effects on Urinary Symptoms

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2024-04-05
• Primary completion: 2026-05-01
• Completion: 2026-12-01
• First posted: 2024-01-19
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States