PACAP-38 Infusion in Patients With Cluster Headache

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-05-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Cluster Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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PACAP-38 infusion

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.

Group Type EXPERIMENTAL

Evaluation of headache inducing capabilities of PACAP38

Intervention Type OTHER

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.

VIP infusion

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.

Group Type ACTIVE_COMPARATOR

Evaluation of headache inducing capabilities of PACAP38

Intervention Type OTHER

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.

Interventions

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Evaluation of headache inducing capabilities of PACAP38

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No