CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

July 31, 2022 updated by: Song Guo, Danish Headache Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Danish Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 90 min after administration of study drug
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
Time Frame: 90 min after administration of study drug
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
Time Frame: 90 min after administration of study drug
Using 90 min headache questionnaire
90 min after administration of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Messoud Ashina, MD, PhD,DMSc, Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-15006836

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cluster Headache

Clinical Trials on Calcitonin-Gene Related Peptide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe