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CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

NCT02466334 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-08-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Danish Headache Center

    lead OTHER

Principal Investigators

  • Messoud Ashina, MD, PhD,DMSc · Danish Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-03-31
Completion
2018-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466334 on ClinicalTrials.gov