Migraine Medication Effects on Urinary Symptoms

NeuroTherapia, Inc.

Status

Invitation-only

Conditions

Interstitial Cystitis

Migraine Disorders

Migraine

Overactive Detrusor

Bladder Pain Syndrome

Overactive Bladder Syndrome

Overactive Bladder

Treatments

Drug: Atogepant

Drug: Ubrogepant

Drug: Erenumab

Drug: Rimegepant

Drug: Botulinum toxin A

Drug: Eptinezumab

Drug: Galcanezumab

Drug: Fremanezumab

Study type

Observational

Funder types

Other

Identifiers

NCT06212661

23-1101

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

CGRP inhibitor

Description:

* Ubrogepant (Ubrelvy™) * Rimegepant (Nurtec®) * Atogepant (Qulipta™) * Eptinezumab (Vyepti®) * Fremanezumab (Ajovy®) * Galcanezumab (Emgality®) * Erenumab (Aimovig®) dosage and duration according to provider's clinical decision.

Treatment: