PACAP-38 Infusion in Patients With Cluster Headache

Danish Headache Center45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Cluster Headache

Interventions

Evaluation of headache inducing capabilities of PACAP38OTHER

We wish to investigate the headache inducing capabilities of PACAP-38, a vasoactive peptide, over a 20 minute infusion. As PACAP-38 casues visible vasodilation, another vasoactive peptide, called VIP will be used as an active comparator.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Danish Headache Center

Glostrup Municipality, Denmark

RECRUITING

Outcomes

Primary Outcomes

Headache

Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion

Time frame: 90 minutes

Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE

Changes in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE

Time frame: 90 minutes

Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion

Difference in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with induced cluster headache and patients without headache

Time frame: 90 minutes

Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline

Difference in plasma/serum concentrations of the following markers at baseline: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE between patients with episodic cluster headache in remission, episodic cluster headache in cluster, and chronic cluster headache

Time frame: 90 minutes

Headache intensity

Difference in AUD for headache intensity scores (0-90 minutes)

Time frame: 90 minutes

Time to headache peak

Difference in time to peak headache between PACAP-38 day and VIP day

Time frame: 90 minutes