Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT04299958
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2020-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Prospective Study on the Presence of Typical Migraine Features in Nummular Headache Patients: The Numamig Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}], 'ancestors': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2020-03-05', 'studyFirstSubmitQcDate': '2020-03-06', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Family history of migraine', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To assess family history of migraine headache in nummular patients. We will build family tree up to 3 generations and we will ask patients to complete it by questioning their relatives.'}, {'measure': 'Epidemiological pattern', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To determine age of onset, age when they were diagnosed, temporal pattern and frequency of headache.'}, {'measure': 'Clinical phenotype', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To assess the clinical characteristics of nummular headache, analyzing the presence of typical features of migraine. Patients will complete a prospective headache diary for 15 days.'}, {'measure': 'Presence of associated symptoms', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To assess the presence of symptoms such as nausea, vomiting, dizziness during the headache episodes.'}, {'measure': 'Presence of prodromes', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To assess the presence of typical migraine prodromes before the headache episodes.'}, {'measure': 'Presence of postdromes', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To assess the presence of typical migraine postdromes after the headache episode.'}, {'measure': 'Presence of sensory disturbances', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To evaluate the presence of sensory changes such as hypoesthesia, hyperalgesia or allodinia upon examination.'}, {'measure': 'Response to acute treatment', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To describe response to prior acute medications.'}, {'measure': 'Response to prophylactic treatment', 'timeFrame': 'Through study completion, an average of 1 month', 'description': 'To assess response to prior prophylactic treatments.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nummular headache'], 'conditions': ['Nummular Headache', 'Migraine', 'Headache Disorders, Primary']}, 'referencesModule': {'references': [{'pmid': '29368949', 'type': 'BACKGROUND', 'citation': 'Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.'}, {'pmid': '12058099', 'type': 'BACKGROUND', 'citation': 'Pareja JA, Caminero AB, Serra J, Barriga FJ, Baron M, Dobato JL, Vela L, Sanchez del Rio M. Numular headache: a coin-shaped cephalgia. Neurology. 2002 Jun 11;58(11):1678-9. doi: 10.1212/wnl.58.11.1678.'}, {'pmid': '30961529', 'type': 'BACKGROUND', 'citation': 'Trigo J, Garcia-Azorin D, Martinez Pias E, Sierra A, Chavarria A, Guerrero AL. Clinical characteristics of nummular headache and differentiation between spontaneous and posttraumatic variant: an observational study. J Headache Pain. 2019 Apr 8;20(1):34. doi: 10.1186/s10194-019-0981-4.'}, {'pmid': '31272194', 'type': 'BACKGROUND', 'citation': 'Garcia-Azorin D, Trigo-Lopez J, Sierra A, Blanco-Garcia L, Martinez-Pias E, Martinez B, Talavera B, Guerrero AL. Observational, open-label, non-randomized study on the efficacy of onabotulinumtoxinA in the treatment of nummular headache: The pre-numabot study. Cephalalgia. 2019 Dec;39(14):1818-1826. doi: 10.1177/0333102419863023. Epub 2019 Jul 4.'}, {'pmid': '29103335', 'type': 'BACKGROUND', 'citation': 'Cuadrado ML, Lopez-Ruiz P, Guerrero AL. Nummular headache: an update and future prospects. Expert Rev Neurother. 2018 Jan;18(1):9-19. doi: 10.1080/14737175.2018.1401925. Epub 2017 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'Observational analytic study with prospective cohort design that aim to describe the presence of typical features of migraine in a cohort of nummular headache patients. The aim of the study is to analyze family history, epidemiology, clinical description, presence of prodromes, postdromes and response to treatment.', 'detailedDescription': 'Background:\n\nNummular headache (NH) is a primary headache included in the International Classification of Headache Disorders (ICHD) characterized by a well delimited superficial pain, with sharp border, felt in a rounded or elliptical 1-6 centimeters area. Pain might be continuous or intermittent. The key feature of nummular headache is the fixed superficial topography.\n\nThe real nature of this condition is still a matter of controversial. Some authors defend it as a specific condition with a particular pathophysiology; whereas others consider that it might be a localized form of migraine with a shared phenotype and pathophysiology.\n\nAmong the arguments that defend its existence as a differentiated entity we include: the older age of onset, the fixed and localized pain without pain in other territories, presence of trophic changes, the localized abnormality in pressure pain threshold determination, the description of secondary cases, the description of posttraumatic cases or the specific therapeutic response.\n\nOn the other hand, in some cases hypersensitivity to stimuli has been described, other typical migrainous symptoms such as nausea or vomiting might be present, and some patients respond to triptans or other migraine prophylactics.\n\nInformation is scarce about the presence of prodromes, postdromes or family history of migraine. Moreover, little is known about NH pathophysiology, some studies suggest an impairment in superficial sensory fibers because a localized alteration of pressure-pain threshold. No imaging or laboratory studies have been done so far.\n\nThis is a proof of concept study. The aim is to analyze if patients with a definite NH diagnosis according to ICHD present any shared epidemiological, clinical or therapeutical features with migraine.\n\nHypothesis:\n\nNummular headache might be a specific condition or it might share migraine biologic features. The detailed description of it might help to clarify whether if NH is a single entity or a focal presentation form of migraine.\n\nObjective:\n\nTo describe the presence of typical features of migraine in a cohort of NH patients, including family history, epidemiology, clinical description, presence of prodromes or postdromes and response to treatment.\n\nMethods:\n\nThe study has an observational analytic design following the Strengthening the Reporting of Observational in Epidemiology (STROBE) guidelines. Patients with definite nummular headache diagnosis according to The International Classification of Headache Disorders1 will be invited to participate. The study will be conducted in the Headache Unit of Hospital Clinico Universitario de Valladolid, a third level hospital sited in Valladolid, with a reference population of 280.000 people.\n\nIntervention:\n\nThe study will be divided into different sections:\n\n1. Family history of headache and in particular, migraine.\n2. Epidemiology of NH patients.\n3. Clinical phenotype and pattern of the headache.\n4. Associated symptoms, presence of prodromes and postdromes.\n5. Physical examination.\n6. Prior treatment use, tolerability and response.\n\nSelection of participants:\n\nRecruitment will be recruited by a non-probabilistic sampling method by convenience and by formal invitation if they are included in the clinical registry of the Headache Unit of the Hospital Clinico Universitario de Valladolid.\n\nIn the first visit participants will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with definite diagnosis of nummular headache that visit the headache outpatient clinic of Valladolid University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Nummular Headache (NH) according to the International Classification of Headache Disorders, 3rd version (ICHD-3).\n2. More than 3 months of NH evolution.\n3. No better accounted for by another ICHD-3 diagnosis.\n4. Older than 18 years.\n5. Capable of prospectively register headache characteristics in a diary.\n6. Ability to provide informed consent form.\n\nExclusion Criteria:\n\n1. Other primary or secondary headache, except for infrequent tension-type headache or medication overuse headache.\n2. Major psychiatric disorders.\n3. Alcoholism or drug use.'}, 'identificationModule': {'nctId': 'NCT04299958', 'briefTitle': 'Observational Prospective Study on the Presence of Typical Migraine Features in Nummular Headache Patients: The Numamig Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clínico Universitario de Valladolid'}, 'officialTitle': 'Observational Prospective Study on the Presence of Typical Migraine Features in Nummular Headache Patients: The Numamig Study', 'orgStudyIdInfo': {'id': 'PI 20-1638'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patient diary', 'type': 'OTHER', 'description': 'In the first visit they will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'To be decided if anonymous data-sheets are available for other researchers upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Clínico Universitario de Valladolid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'David García Azorín', 'investigatorAffiliation': 'Hospital Clínico Universitario de Valladolid'}}}}