Clinical trial NCT03814226: PACAP-38 Infusion in Patients With Cluster Headache
Official title: The Effect of PACAP-38 Infusion in Inducing Headache in Patients With Cluster Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cluster Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized, double-blinded, two-way crossover study investigating the headache inducing capabilities of PACAP-38 in patients with cluster headache. Forty-five patients (15 episodic patients in cluster, 15, episodic patients in remission and 15 chronic cluster headache patients) are expected to participate. Each patients will on two separate study days in a randomized way receive an infusion of PACAP-38 and VIP over 20 minutes followed by an observation period of 70 minutes. Blood samples for investigation of VIP, PACAP38; CGRP, NSE, Histamine and Tryptase will be drawn at fixed time-points during experiment.


Eligibility criteria: Inclusion Criteria:

* Episodic or chronic cluster headache according to international classification of headache disorders
* Age 18-65 years
* Weight 50-100 kg
* If women of childbearing potential, then must use safe contraceptives

Exclusion Criteria:

* Episodic tension-type headache \> 15 days per month
* Other primary headache disorders, except tension-type headache \< 5 days per month
* Episodic cluster headache patients outside cluster must be completely headache free a minimum of 8 hours prior to experiment
* Episodic cluster headache patients in cluster and chronic cluster headache patients must be completely headache free a minimum of 4 hours prior to experiment
* Current or recent use (30 days) of injected or oral corticosteroids
* Pregnant or lactating women
* A history or clinical signs of hypertension (BP \> 150mmHg systolic / 100mmHg diastolic)
* A history or clinical signs of hypotension (BP \<90 mmHg systolic / 50mmHg diastolic)
* A history of cardiovascular or cerebrovascular disease
* A history of psychiatric disease or substance abuse
* A medical history or clinical signs of disease that according to investigator would preclude participation in the study

Primary outcomes:
measure: Headache
timeFrame: 90 minutes
measure: Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE
timeFrame: 90 minutes
measure: Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion
timeFrame: 90 minutes
measure: Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline
timeFrame: 90 minutes
measure: Headache intensity
timeFrame: 90 minutes
measure: Time to headache peak
timeFrame: 90 minutes
Secondary outcomes:
measure: Change in mean arterial blood pressure
timeFrame: 90 minutes
measure: Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE
timeFrame: Baseline
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pellesi L, Chaudhry BA, Vollesen ALH, Snoer AH, Baumann K, Skov PS, Jensen RH, Ashina M. PACAP38- and VIP-induced cluster headache attacks are not associated with changes of plasma CGRP or markers of mast cell activation. Cephalalgia. 2022 Jul;42(8):687-695. doi: 10.1177/03331024211056248. Epub 2021 Nov 25.
citation: Vollesen ALH, Snoer A, Chaudhry B, Petersen AS, Hagedorn A, Hoffmann J, Jensen RH, Ashina M. The effect of pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide in cluster headache. Cephalalgia. 2020 Nov;40(13):1474-1488. doi: 10.1177/0333102420940689. Epub 2020 Sep 22.