PACAP-38 Infusion in Patients With Cluster Headache

Cluster Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03814226
• Other study ID #: H-17011569
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 5, 2020

Study information

• Verified date: January 2019
• Source: Danish Headache Center
• Contact: Agneta Snoer, MD
• Phone: + 45 26274040
• Email: agneta.henriette.snoer.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 5, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

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.

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache	Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion	90 minutes
Primary	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	90 minutes
Primary	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	90 minutes
Primary	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	90 minutes
Primary	Headache intensity	Difference in AUD for headache intensity scores (0-90 minutes)	90 minutes
Primary	Time to headache peak	Difference in time to peak headache between PACAP-38 day and VIP day	90 minutes
Secondary	Change in mean arterial blood pressure	Difference in area under the curve (AUC) for mean arterial pressure (based on systolic and diastolic measurements) and heart rate during experiment	90 minutes
Secondary	Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE	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