Cluster Headache
Conditions
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.
Interventions
DRUGCalcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
DRUGPlacebo
40 ml of normal saline over 20 mins
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Denmark
Outcome results
None listed