DRUG
Calcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients
Status
Completed
Phase
Not applicable
Enrollment
37
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
40 ml of normal saline over 20 mins
Timeline
From registration to results.
First posted
Jun 9, 2015
Study start
Jun 2015
Primary completion
Mar 2017
Study completion
Dec 2018
Results posted
Not reported
Registry updated
Aug 2, 2022
Outcomes
What the study measures.
Primary outcomes
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
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
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
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Danish Headache Center
Copenhagen, Glostrup, Denmark
Publications
Results and literature.
Related trials
More studies on Calcitonin.
NCT IDStudyPhase / statusEnrollmentUpdated
Long-term Atogepant in Real-world Practice
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Migraine · Headache
Not applicable
Completed
513
2026-07
Different Kinematics Within a Single-File System and Postoperative Pain
Jordan University of Science and Technology · Root Canal Treatment · Postoperative Pain
Not applicable
Active, not recruiting
75
2026-07
Subcutaneous Calcitonin in Acute Herpes Zoster
Tanta University · Calcitonin · Subcutaneous
Phase 3
Recruiting
168
2026-07
Calcitonin Gene-related Peptide Antibody in Acute Mountain Sickness
Insel Gruppe AG, University Hospital Bern · Acute Mountain Sickness
Phase 4
Not yet recruiting
30
2026-07
Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin
Institut Claudius Regaud · Medullary Thyroid Cancer
Not applicable
Completed
24
2026-06
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
Rigmor Højland Jensen · Idiopathic Intracranial Hypertension (IIH)
Phase 3
Not yet recruiting
96
2026-06
i-NEED: NEw migrainE Drugs Database
IRCCS San Raffaele Roma · Episodic Migraine · Chronic Migraine
Not applicable
Recruiting
2,641
2026-06
Mulligan Mobilization and Stabilization Exercises for Sensorimotor Function in Women With Text Neck Syndrome
Pamukkale University · Neck Pain · Text Neck Syndrome
Not applicable
Completed
38
2026-05
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.