NCT02466334

Brief 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. 1.Provoking ECH patients in bout with CGRP triggers cluster headache attacks
  2. 2.Provoking ECH patients in remission with CGRP does not trigger cluster headache attacks
  3. 3.Provoking chronic cluster headache patients with CGRP triggers cluster headache attacks more often than in ECH patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

May 21, 2015

Last Update Submit

July 31, 2022

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Active

ACTIVE COMPARATOR

1.5µg/min IV calcitonin-gene related peptide for 20 minutes

Drug: Calcitonin-Gene Related Peptide

Placebo

PLACEBO COMPARATOR

IV placebo for 20 minutes

Drug: Placebo

Interventions

Calcitonin-Gene Related PeptideDRUG

1,5 µg/min of IV CGRP over 20 mins

Also known as: CGRP
Active
PlaceboDRUG

40 ml of normal saline over 20 mins

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center

Copenhagen, Glostrup, 2600, Denmark

Location

Related Publications (1)

  • Vollesen ALH, Snoer A, Beske RP, Guo S, Hoffmann J, Jensen RH, Ashina M. Effect of Infusion of Calcitonin Gene-Related Peptide on Cluster Headache Attacks: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1187-1197. doi: 10.1001/jamaneurol.2018.1675.

    PMID: 29987329DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

CalcitoninSaline Solution

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsThyroid HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Messoud Ashina, MD, PhD,DMSc

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Ph.d. student

Study Record Dates

First Submitted

May 21, 2015

First Posted

June 9, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2017

Study Completion

December 1, 2018

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations

DK(1)