PACAP-38 Infusion in Patients With Cluster Headache
- Conditions
- Cluster Headache
- Interventions
- Other: Evaluation of headache inducing capabilities of PACAP38
- Registration Number
- NCT03814226
- Lead Sponsor
- Danish Headache Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PACAP-38 infusion Evaluation of headache inducing capabilities of PACAP38 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. VIP infusion Evaluation of headache inducing capabilities of PACAP38 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.
- Primary Outcome Measures
Name Time Method 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
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)
Time to headache peak 90 minutes Difference in time to peak headache between PACAP-38 day and VIP day
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Danish Headache Center
🇩🇰Glostrup, Denmark