PACAP-38 Infusion in Patients With Cluster Headache
Cluster Headache
About this trial
This is an interventional basic science trial for Cluster Headache
Eligibility Criteria
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
Sites / Locations
- Danish Headache CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PACAP-38 infusion
VIP 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.
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.