CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

NCT02466334 — Not applicable, Completed, 37 participants, Danish Headache Center

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Registry	NCT02466334
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, basic science
Enrollment	37 (Actual)
Sponsor	Danish Headache Center (Other)
Conditions	Cluster Headache
Interventions	Calcitonin-Gene Related Peptide, Placebo (Drug)
Dates	start 2015-06-01, primary completion 2017-03-01, completion 2018-12-01, first posted 2015-06-09, last updated 2022-08-02
Locations	1 site in Denmark

-Summary

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.

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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+Arms and interventions

Arm	Type	Interventions	Description
Active	Active comparator	Drug: Calcitonin-Gene Related Peptide	1.5µg/min IV calcitonin-gene related peptide for 20 minutes
Placebo	Placebo comparator	Drug: Placebo	IV placebo for 20 minutes

Calcitonin-Gene Related Peptide (Drug), also known as CGRP: 1,5 µg/min of IV CGRP over 20 mins
Placebo (Drug), also known as Normal saline: 40 ml of normal saline over 20 mins

+Outcome measures

Primary outcomes

Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups [90 min after administration of study drug]: Occurence of experimentally induced cluster headache attack yes/no
AUC headache on CGRP day compared to placebo day in all three groups [90 min after administration of study drug]: Using 90 min headache questionnaire
Time to maximum headache score on CGRP day compared to placebo day in all three [90 min after administration of study drug]: Using 90 min headache questionnaire

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Fulfillment of IHS criteria for cluster headache either chronic or episodic
* 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:

* All other primary types of headache
* 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

+Locations (1)

Facility	City	Country	Status
Danish Headache Center	Copenhagen, Glostrup	Denmark

+Publications

Results publication: 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. PMID 29987329

+Investigators

Messoud Ashina, MD, PhD,DMSc, Principal investigator, Danish Headache Center