CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

Cluster Headache Clinical Trial

Official title:

CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466334
• Other study ID #: H-15006836
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2022
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Drug:
• Calcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
• Placebo
40 ml of normal saline over 20 mins

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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