Migraine Medication Effects on Urinary Symptoms
Launched by THE CLEVELAND CLINIC · Jan 9, 2024
Trial Information
Current as of July 25, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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/pel...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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).
- Exclusion Criteria:
- • 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.
About The Cleveland Clinic
The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Patients applied
Trial Officials
Howard B Goldman, MD
Principal Investigator
The Cleveland Clinic
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported