PACAP-38 Infusion in Patients With Cluster Headache

The Effect of PACAP-38 Infusion in Inducing Headache in Patients With Cluster Headache

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.

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