Clinical trial NCT02466334: CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Official title: CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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
measure: AUC headache on CGRP day compared to placebo day in all three groups
timeFrame: 90 min after administration of study drug
measure: Time to maximum headache score on CGRP day compared to placebo day in all three
timeFrame: 90 min after administration of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Glostrup
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD, PhD,DMSc
role: PRINCIPAL_INVESTIGATOR
References:
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.