CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
NCT ID: NCT02466334
Last Updated: 2022-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2015-06-30
2018-12-31
Brief Summary
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The 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.
Based on the above the investigators hypothesize the following:
1. Provoking ECH patients in bout with CGRP triggers cluster headache attacks
2. Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
3. Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Active
1.5µg/min IV calcitonin-gene related peptide for 20 minutes
Calcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
Placebo
IV placebo for 20 minutes
Placebo
40 ml of normal saline over 20 mins
Interventions
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Calcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
Placebo
40 ml of normal saline over 20 mins
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients in bouts 1-32 attacks per week
* Patients in remission minimum of 1 month remission time
* fertile women must use safe contraception
Exclusion Criteria
* headache 8 hours or less before study day begins
* pregnant or lactating women
* 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
18 Years
65 Years
ALL
No
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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Song Guo
Medical doctor, Ph.d. student
Principal Investigators
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Messoud Ashina, MD, PhD,DMSc
Role: PRINCIPAL_INVESTIGATOR
Danish Headache Center
Locations
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Danish Headache Center
Copenhagen, Glostrup, Denmark
Countries
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References
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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.
Other Identifiers
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H-15006836
Identifier Type: -
Identifier Source: org_study_id
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