CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

Study Overview
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Brief Summary
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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: Provoking ECH patients in bout with CGRP triggers cluster headache attacks Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.

Official Title
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CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

Conditions
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Cluster Headache

Intervention / Treatment
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* Drug: Calcitonin-Gene Related Peptide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>1.5µg/min IV calcitonin-gene related peptide for 20 minutes | Drug: Calcitonin-Gene Related Peptide<br>* 1,5 µg/min of IV CGRP over 20 mins<br>* Other names: CGRP;|
| Placebo Comparator: Placebo<br>IV placebo for 20 minutes | Drug: Placebo<br>* 40 ml of normal saline over 20 mins<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups | Occurence of experimentally induced cluster headache attack yes/no | 90 min after administration of study drug | 
| AUC headache on CGRP day compared to placebo day in all three groups | Using 90 min headache questionnaire | 90 min after administration of study drug | 
| Time to maximum headache score on CGRP day compared to placebo day in all three | Using 90 min headache questionnaire | 90 min after administration of study drug |