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CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

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ClinicalTrials.gov Identifier: NCT02466334
Recruitment Status : Unknown
Verified December 2017 by Song Guo, Danish Headache Center.
Recruitment status was:  Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Song Guo, Danish Headache Center

Study Description
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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. 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.

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Calcitonin-Gene Related Peptide Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Study Start Date : June 2015
Actual Primary Completion Date : March 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Calcitonin

Arms and Interventions
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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 Name: CGRP
Placebo Comparator: Placebo
IV placebo for 20 minutes
 Drug: Placebo
40 ml of normal saline over 20 mins
Other Name: Normal saline


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466334


Locations
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Denmark
Danish Headache Center
Copenhagen, Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Messoud Ashina, MD, PhD,DMSc Danish Headache Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Song Guo, Medical doctor, Ph.d. student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02466334    
Other Study ID Numbers: H-15006836
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Calcitonin
Salmon calcitonin
Calcitonin Gene-Related Peptide
Katacalcin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Vasodilator Agents