Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-26 @ 3:33 PM
Study NCT ID:
NCT01845051
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2013-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is There a Comorbidity Between Migraine and Allergic Rhinitis?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'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'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-01', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'İnferior turbinate color and edema', 'timeFrame': '1 day', 'description': 'inferior concha colour (0=natural, 1=pale, 2=bluish and 3=severely pale or bluish) and turbinate edema were assessed during ENT examination on 0-3 scale (0 = no, 1 = mild, 2 = moderate, 3 = severe).'}], 'primaryOutcomes': [{'measure': 'Specific Immunoglobulin E (IgE)', 'timeFrame': '1 day', 'description': 'Blood samples were taken from study and control group for the determination of Specific IgE panel against six different allergens: (1) fungi, (2) grass pollens, (3) tree pollens, (4) wild herbs, (5) mite 1, (6) mite 2. For all of specific IgE panels, \\<0,7 RU/ml was negative; and \\>0,7 RU/ml was Positive.'}, {'measure': 'Nasal Symptom Scores', 'timeFrame': '1 day', 'description': 'Symptoms were assessed with a questionnaire for the presence and severity of allergic rhinitis (AR) symptoms on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). Symptoms of AR (Nasal discharge, nasal congestion, itching and sneezing) were graded between 0-3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'allergic rhinitis', 'Specific Immunoglobulin E (IgE)', 'nasal symptoms', 'signs of allergy.'], 'conditions': ['Migraine', 'Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The researchers investigated the relationship between migraine and allergy. For this purpose, the researchers designed a controlled study to evaluate nasal symptoms and signs; and to perform Specific Immunoglobulin E (IgE) measurements in migraine patients and healthy subjects. According to these results the prevalence of allergic rhinitis in migraine group was planned to be compared to that of the healthy controls, statistically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Migraine patients attending neurology clinic and healthy subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with migraine\n\nExclusion Criteria:\n\n* other neurologic disorders that may contribute to headaches, such as stroke, cerebral palsy, trigeminal neuralgia, and seizure disorder\n* also acute and chronic sinusitis.'}, 'identificationModule': {'nctId': 'NCT01845051', 'briefTitle': 'Is There a Comorbidity Between Migraine and Allergic Rhinitis?', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'orgStudyIdInfo': {'id': 'CC-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine group', 'description': 'Patients diagnosed with migraine'}, {'label': 'Healthy group', 'description': 'Healthy subjects with no migraine as control'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, ENT Specialist', 'investigatorFullName': 'Işıl Adadan Güvenç', 'investigatorAffiliation': 'Baskent University'}}}}