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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02466334
Other study ID # H-15006836
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2018

Study information

Verified date July 2022
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date December 2018
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Calcitonin-Gene Related Peptide
1,5 µg/min of IV CGRP over 20 mins
Placebo
40 ml of normal saline over 20 mins

Locations

Country Name City State
Denmark Danish Headache Center Copenhagen Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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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