NCT02466334

CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Danish Headache Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	Calcitonin-Gene Related Peptide	1,5 µg/min of IV CGRP over 20 mins
DRUG	Placebo	40 ml of normal saline over 20 mins

Timeline

• Start date: 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 across 1 country: Denmark