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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | 1.5µg/min IV calcitonin-gene related peptide for 20 minutes |
|
| Placebo | Placebo Comparator | IV placebo for 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitonin-Gene Related Peptide | Drug | 1,5 µg/min of IV CGRP over 20 mins |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, MD, PhD,DMSc | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Copenhagen | Glostrup | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29987329 | Derived | 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. |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D002116 | Calcitonin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D013963 | Thyroid Hormones |
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| Placebo | Drug | 40 ml of normal saline over 20 mins |
|
|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |