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
About this trial
This is an interventional basic science trial for Cluster Headache
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
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
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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