Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06212661
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06212661
Study Brief:
Protocol Section:
NCT06212661