Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 2:56 PM
Study NCT ID:
NCT03542357
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sumatriptan and Placebo on CGRP Induced Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015740', 'term': 'Calcitonin Gene-Related Peptide'}, {'id': 'D018170', 'term': 'Sumatriptan'}], 'ancestors': [{'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC after infusion', 'timeFrame': '1 year', 'description': 'The investigators will assess the outcome measures 1 year after the beginning of the study'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.', 'detailedDescription': "There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Calcitonine Gene Related Peptide (CGRP) induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.\n\nHypothesis: CGRP induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.\n\nAim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nHealthy:\n\nHealthy subjects of both sexes Age 18-60 years Weight 45-95 kg. Females were requested to use effective contraception.\n\nMigraine patients:\n\nMigraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg.\n\nExclusion Criteria:\n\nHealthy:\n\nAny type of headache (except episodic tension-type headache \\< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).\n\nMigraine patients:\n\nAny other type of headache then migraine without aura (except episodic tension-type headache \\< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders'}, 'identificationModule': {'nctId': 'NCT03542357', 'briefTitle': 'The Effect of Sumatriptan and Placebo on CGRP Induced Headache', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'The Effect of Sumatriptan and Placebo on CGRP Induced Headache', 'orgStudyIdInfo': {'id': 'H-16000065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sumatriptan', 'description': 'headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment', 'interventionNames': ['Drug: Calcitonin Gene Related Peptide', 'Drug: Sumatriptan 50 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment', 'interventionNames': ['Drug: Calcitonin Gene Related Peptide', 'Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Calcitonin Gene Related Peptide', 'type': 'DRUG', 'otherNames': ['CGRP'], 'description': 'CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan', 'armGroupLabels': ['Placebo', 'Sumatriptan']}, {'name': 'Sumatriptan 50 mg', 'type': 'DRUG', 'otherNames': ['Imigran'], 'description': 'CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan', 'armGroupLabels': ['Sumatriptan']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Rigshospitalet Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Katrine Falkenberg', 'investigatorAffiliation': 'Danish Headache Center'}}}}