NCT06212661Enrolling by invitation
Migraine Medication Effects on Urinary Symptoms
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 9 Jan 2024
- Start date
- 5 Apr 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Migraine
- NCT number
- NCT06212661
What you commit to
- Study type: Observational
- Planned participants: 200
- From 5 Apr 2024 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bladder BoNTA in last 12 months.
Age
- Age \< 18 years
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.