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CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

Primary Purpose

Cluster Headache

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcitonin-Gene Related Peptide
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cluster Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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

IV placebo for 20 minutes

Outcomes

Primary Outcome Measures

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
AUC headache on CGRP day compared to placebo day in all three groups
Using 90 min headache questionnaire
Time to maximum headache score on CGRP day compared to placebo day in all three
Using 90 min headache questionnaire

Secondary Outcome Measures

Full Information

First Posted
May 21, 2015
Last Updated
July 31, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT02466334
Brief Title
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Official Title
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
1.5µg/min IV calcitonin-gene related peptide for 20 minutes
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV placebo for 20 minutes
Intervention Type
Drug
Intervention Name(s)
Calcitonin-Gene Related Peptide
Other Intervention Name(s)
CGRP
Intervention Description
1,5 µg/min of IV CGRP over 20 mins
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
40 ml of normal saline over 20 mins
Primary Outcome Measure Information:
Title
Differences in occurence of cluster headache attacks on CGRP day compared to placebo day in all three groups
Description
Occurence of experimentally induced cluster headache attack yes/no
Time Frame
90 min after administration of study drug
Title
AUC headache on CGRP day compared to placebo day in all three groups
Description
Using 90 min headache questionnaire
Time Frame
90 min after administration of study drug
Title
Time to maximum headache score on CGRP day compared to placebo day in all three
Description
Using 90 min headache questionnaire
Time Frame
90 min after administration of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD, PhD,DMSc
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29987329
Citation
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.
Results Reference
derived

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CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients

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