PACAP-38 Infusion in Patients With Cluster Headache

Danish Headache Center

Status: Unknown

Conditions: Cluster Headache

Treatments: Other: Evaluation of headache inducing capabilities of PACAP38

Study type: Interventional

Funder types: Other

Identifiers

NCT03814226

H-17011569

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 2 patient groups

PACAP-38 infusion

Experimental group

Description:

According to main hypothesis PACAP-38 is expected to induce headache. PACAP-38 causes marked vasodilation visible to investigator. PACAP38 (10 pmol/kg/min) is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.

Treatment:

Other: Evaluation of headache inducing capabilities of PACAP38

VIP infusion

Active Comparator group

Description:

According to main hypothesis VIP is not expected to induce headache. VIP also causes marked vasodilation visible to investigator, which is why VIP is chosen as an active comparator. VIP (10 pmol/kg/min) is infused over 20 minutes. VIP is infused over 20 minutes, patients are observed before (15 minutes), during and after (70 minutes) infusion. Blood samples are drawn at fixed time-points.

Treatment:

Other: Evaluation of headache inducing capabilities of PACAP38