Cluster Headache
Conditions
Brief 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.
Interventions
OTHEREvaluation 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.
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to headache peak | 90 minutes | Difference in time to peak headache between PACAP-38 day and VIP day |
| Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE at baseline | 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 |
| Headache intensity | 90 minutes | Difference in AUD for headache intensity scores (0-90 minutes) |
| Headache | 90 minutes | Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion |
| Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE | 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 |
| Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE after infusion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE | 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 |
| Change in mean arterial blood pressure | 90 minutes | Difference in area under the curve (AUC) for mean arterial pressure (based on systolic and diastolic measurements) and heart rate during experiment |
Countries
Denmark
Contacts
Primary ContactAgneta Snoer, MD
Backup ContactLuise Vollsen, MD
Outcome results
None listed