Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-03 @ 8:57 AM
Study NCT ID:
NCT02466334
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003027', 'term': 'Cluster Headache'}], 'ancestors': [{'id': 'D051303', 'term': 'Trigeminal Autonomic Cephalalgias'}, {'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': 'D002116', 'term': 'Calcitonin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-06-04', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups', 'timeFrame': '90 min after administration of study drug', 'description': 'Occurence of experimentally induced cluster headache attack yes/no'}, {'measure': 'AUC headache on CGRP day compared to placebo day in all three groups', 'timeFrame': '90 min after administration of study drug', 'description': 'Using 90 min headache questionnaire'}, {'measure': 'Time to maximum headache score on CGRP day compared to placebo day in all three', 'timeFrame': '90 min after administration of study drug', 'description': 'Using 90 min headache questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cluster Headache']}, 'referencesModule': {'references': [{'pmid': '29987329', 'type': 'DERIVED', 'citation': 'Vollesen ALH, Snoer A, Beske RP, Guo S, Hoffmann J, Jensen RH, Ashina M. Effect of Infusion of Calcitonin Gene-Related Peptide on Cluster Headache Attacks: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1187-1197. doi: 10.1001/jamaneurol.2018.1675.'}]}, 'descriptionModule': {'briefSummary': 'It has previously been shown that nitroglycerine induces cluster headache attacks in episodic cluster headache patients (ECH patients) in bouts but not in remission phase. Furthermore, plasma concentrations of calcitonin gene-related peptide (CGRP) have been shown to be significantly higher during, but not before and after, an attack.\n\nThe attack appears around 20-40 min after nitroglycerine infusion with vasodilatation. During this latency period preceding the attack, no increase in CGRP plasma concentrations is seen. CGRP induces migraine attacks in 65% of migraine patients, and CGRP antagonists as well as monoclonal antibodies against CGRP are effective in migraine treatment.\n\nBased on the above the investigators hypothesize the following:\n\n1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks\n2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks\n3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fulfillment of IHS criteria for cluster headache either chronic or episodic\n* Patients in bouts 1-32 attacks per week\n* Patients in remission minimum of 1 month remission time\n* fertile women must use safe contraception\n\nExclusion Criteria:\n\n* All other primary types of headache\n* headache 8 hours or less before study day begins\n* pregnant or lactating women\n* any history or clinical sigs of hyper/hypotension, heart disease, mental disorder, substance abuse, or other illness deemed relevant by the medical doctor assessing the patient'}, 'identificationModule': {'nctId': 'NCT02466334', 'briefTitle': "CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients", 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': "CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients", 'orgStudyIdInfo': {'id': 'H-15006836'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': '1.5µg/min IV calcitonin-gene related peptide for 20 minutes', 'interventionNames': ['Drug: Calcitonin-Gene Related Peptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'IV placebo for 20 minutes', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Calcitonin-Gene Related Peptide', 'type': 'DRUG', 'otherNames': ['CGRP'], 'description': '1,5 µg/min of IV CGRP over 20 mins', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': '40 ml of normal saline over 20 mins', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'country': 'Denmark', 'facility': 'Danish Headache Center', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Messoud Ashina, MD, PhD,DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Headache Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, Ph.d. student', 'investigatorFullName': 'Song Guo', 'investigatorAffiliation': 'Danish Headache Center'}}}}