Trials / Unknown
UnknownNCT03814226
PACAP-38 Infusion in Patients With Cluster Headache
The Effect of PACAP-38 Infusion in Inducing Headache in Patients With Cluster Headache
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Danish Headache Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-01-01
- Completion
- 2020-05-05
- First posted
- 2019-01-23
- Last updated
- 2019-01-23
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03814226. Inclusion in this directory is not an endorsement.