PACAP-38 Infusion in Patients With Cluster Headache

January 22, 2019 updated by: Agneta Snoer, Danish Headache Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Glostrup, Denmark, 2620
        • Recruiting
        • Danish Headache Center
        • Contact:
        • Sub-Investigator:
          • Anne Luise Vollesen, MD
        • Principal Investigator:
          • Messoud Ashina, DMSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache
Time Frame: 90 minutes
Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion
90 minutes
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE
Time Frame: 90 minutes
Changes in plasma/serum concentrations of the following markers after infusion of PACAP-38 and VIP: PACAP-38, VIP, CGRP, Histamine, Tryptase, NSE
90 minutes
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion
Time Frame: 90 minutes
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
90 minutes
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline
Time Frame: 90 minutes
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
90 minutes
Headache intensity
Time Frame: 90 minutes
Difference in AUD for headache intensity scores (0-90 minutes)
90 minutes
Time to headache peak
Time Frame: 90 minutes
Difference in time to peak headache between PACAP-38 day and VIP day
90 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean arterial blood pressure
Time Frame: 90 minutes
Difference in area under the curve (AUC) for mean arterial pressure (based on systolic and diastolic measurements) and heart rate during experiment
90 minutes
Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE
Time Frame: Baseline
Difference in serum/plasma levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline in patients who develop a cluster headache attack compared to those who do not
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Messoud Ashina, Professor, Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

May 5, 2020

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17011569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cluster Headache

Clinical Trials on Evaluation of headache inducing capabilities of PACAP38

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe