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OpenTrials
Completed

NCT Number: NCT02466334

CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

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.

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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcitonin-Gene Related Peptide

Drug

1,5 µg/min of IV CGRP over 20 mins

Other names: CGRP

Placebo

Drug

40 ml of normal saline over 20 mins

Other names: Normal saline

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 9, 2015
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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