Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-06 @ 7:04 AM
Study NCT ID:
NCT06212661
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-01
First Post:
2024-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Migraine Medication Effects on Urinary Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D018856', 'term': 'Cystitis, Interstitial'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615620', 'term': 'ubrogepant'}, {'id': 'C578443', 'term': 'rimegepant sulfate'}, {'id': 'C000718987', 'term': 'atogepant'}, {'id': 'C000628361', 'term': 'eptinezumab'}, {'id': 'C000604315', 'term': 'fremanezumab'}, {'id': 'C000605816', 'term': 'erenumab'}, {'id': 'C000628360', 'term': 'galcanezumab'}, {'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2024-01-09', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in OAB symptoms', 'timeFrame': '3 months', 'description': 'To prospectively compare changes in OAB symptoms after beginning CGRP inhibitor treatment for migraine, with changes after beginning local BoNTA injections for migraine as controls.\n\nOAB symptom change will be measured using the International Consultation on Incontinence Questionnaire (ICIQ) - Female Lower Urinary Tract Symptoms (FLUTS). ICIQ-FLUTS questionnaire composite OAB score, including urgency, frequency, nocturia and urge incontinence domains (range: 0-16, higher scores indicate worse symptoms). Differences of 2-4 points with a standard deviation of 3-4 points were reported as significant in the literature.'}], 'secondaryOutcomes': [{'measure': 'changes in bladder pain symptoms', 'timeFrame': '3 months', 'description': 'To prospectively compare changes in bladder pain symptoms after beginning CGRP inhibitor treatment for migraine, with changes after beginning local BoNTA injections for migraine as controls.\n\nBladder / pelvic pain symptom change will be measured using the Female Genitourinary Pain Index (GUPI). The score ranges from 0 to 39, quality of life question score from 0 to 6, and higher scores indicate worse symptoms.'}, {'measure': 'rates of LUTS and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.', 'timeFrame': '3 months', 'description': 'To assess rates of LUTS (Lower Urinary Tract Symptoms) and LUTS-related quality of life (QoL) in patients with chronic refractory migraine.\n\nLUTS will be assessed using the International Consultation on Incontinence Questionnaire (ICIQ) - Female Lower Urinary Tract Symptoms (FLUTS). This questionnaire has 12 symptoms questions scored 0 to 4, overall questionnaire score is 0 to 48 points, and higher scores indicate worse symptoms.\n\nBladder / pelvic pain symptoms will be measured using the Female Genitourinary Pain Index (GUPI). The score ranges from 0 to 39, higher scores indicate worse symptoms.\n\nLUTS-related quality of life question, adopted from the international prostate symptom score (IPSS) or American Urological Association symptom index (AUASI), is scored 0 to 6 and a higher score indicated worse quality of life.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder', 'Bladder Pain Syndrome', 'Migraine Disorders', 'Overactive Bladder Syndrome', 'Overactive Detrusor', 'Migraine', 'Interstitial Cystitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients age 18 years or over, presenting to the neurology outpatient clinics for treatment of refractory migraine with either CGRP inhibitors or Botulinum toxin extracranial muscle injections, and with at least 1 urinary storage-phase symptom in the past month.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Patients \\> 18 years\n* Refractory migraine, planned treatment with either:\n* CGRP inhibitors, including:\n\n * CGRP small molecule receptor antagonists ("gepants"): Ubrogepant, Rimegepant, Atogepant.\n * CGRP monoclonal antibodies: Eptinezumab, Fremanezumab, Galcanezumab.\n * CGRP receptor monoclonal antibodies: Erenumab.\n* BoNTA extracranial muscle injections\n* Any of the following symptoms during the last month:\n\n * Urinating too often (frequency).\n * Having a sudden urge to urinate that\'s difficult to hold back (urgency).\n * Having a sudden urge to urinate and urine leaking before you make it to the toilet (urge incontinence).\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* CGRP treatment within the last 12 months or BoNTA (head / bladder) last 6 months.\n* Patient (or medical decision-maker) unable to provide informed consent or unable to answer questionnaire.\n* Unable to urinate, eg: post cystectomy, indwelling catheter, on intermittent self catheterization, ESRD w/ anuria.\n* Prior bladder BoNTA in last 12 months.'}, 'identificationModule': {'nctId': 'NCT06212661', 'briefTitle': 'Migraine Medication Effects on Urinary Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Migraine Medication Effects on Urinary Symptoms', 'orgStudyIdInfo': {'id': '23-1101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CGRP inhibitor', 'description': "* Ubrogepant (Ubrelvy™)\n* Rimegepant (Nurtec®)\n* Atogepant (Qulipta™)\n* Eptinezumab (Vyepti®)\n* Fremanezumab (Ajovy®)\n* Galcanezumab (Emgality®)\n* Erenumab (Aimovig®) dosage and duration according to provider's clinical decision.", 'interventionNames': ['Drug: Ubrogepant', 'Drug: Rimegepant', 'Drug: Atogepant', 'Drug: Eptinezumab', 'Drug: Fremanezumab', 'Drug: Galcanezumab', 'Drug: Erenumab']}, {'label': 'BoNTA extracranial muscle injections', 'description': "Botolinum toxin A (Botox) Injection into extracranial muscles to treat migraine. Dosage and duration according to provider's clinical decision", 'interventionNames': ['Drug: Botulinum toxin A']}], 'interventions': [{'name': 'Ubrogepant', 'type': 'DRUG', 'otherNames': ['Ubrelvy'], 'description': 'Ubrogepant (Ubrelvy™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Rimegepant', 'type': 'DRUG', 'otherNames': ['Nurtec'], 'description': 'Rimegepant (Nurtec®), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Atogepant', 'type': 'DRUG', 'otherNames': ['Qulipta'], 'description': 'Atogepant (Qulipta™), oral, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Eptinezumab', 'type': 'DRUG', 'otherNames': ['Vyepti'], 'description': 'Eptinezumab (Vyepti®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Fremanezumab', 'type': 'DRUG', 'otherNames': ['Ajovy'], 'description': 'Fremanezumab (Ajovy®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Galcanezumab', 'type': 'DRUG', 'otherNames': ['Emgality'], 'description': 'Galcanezumab (Emgality®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Erenumab', 'type': 'DRUG', 'otherNames': ['Aimovig'], 'description': 'Erenumab (Aimovig®) injection, dosage at discretion of clinical provider, for treatment of migraine headaches.', 'armGroupLabels': ['CGRP inhibitor']}, {'name': 'Botulinum toxin A', 'type': 'DRUG', 'otherNames': ['Botox'], 'description': 'Botolinum toxin A (Botox) injections into extracranial muscles, dosage at discretion of clinical provider, for treatment of migraines.', 'armGroupLabels': ['BoNTA extracranial muscle injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic, Main Campus', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Howard B Goldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator / Professor and Vice Chair (Quality and Patient Safety) Glickman Urologic and Kidney Institute', 'investigatorFullName': 'Howard Goldman, MD', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}