Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PACAP-38 infusion | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of headache inducing capabilities of PACAP38 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Headache | Difference in incidence of headache within 90 minutes of infusion between PACAP-38 infusion and VIP infusion | 90 minutes |
| 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 |
| 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 |
| 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 |
| Headache intensity | Difference in AUD for headache intensity scores (0-90 minutes) | 90 minutes |
| Time to headache peak | Difference in time to peak headache between PACAP-38 day and VIP day | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma/serum levels of PACAP-38, VIP, CGRP, Histamine, Tryptase and NSE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agneta Snoer, MD | Contact | + 45 26274040 | agneta.henriette.snoer.02@regionh.dk | |
| Luise Vollsen, MD | Contact | +45 25732284 | luisevollsen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Messoud Ashina, Professor | Danish Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Recruiting | Glostrup Municipality | 2620 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37143998 | Derived | Deligianni C, Pellesi L, Chaudhry BA, Haulund Vollesen AL, Snoer AH, Hannibal J, Jensen RH, Ashina M. Plasma levels of VIP are not elevated during PACAP- and VIP-induced cluster headache attacks: an exploratory study. Front Neurol. 2023 Apr 18;14:1135246. doi: 10.3389/fneur.2023.1135246. eCollection 2023. | |
| 34822741 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| Pellesi L, Chaudhry BA, Vollesen ALH, Snoer AH, Baumann K, Skov PS, Jensen RH, Ashina M. PACAP38- and VIP-induced cluster headache attacks are not associated with changes of plasma CGRP or markers of mast cell activation. Cephalalgia. 2022 Jul;42(8):687-695. doi: 10.1177/03331024211056248. Epub 2021 Nov 25. |
| 32962406 | Derived | Vollesen ALH, Snoer A, Chaudhry B, Petersen AS, Hagedorn A, Hoffmann J, Jensen RH, Ashina M. The effect of pituitary adenylate cyclase-activating peptide-38 and vasoactive intestinal peptide in cluster headache. Cephalalgia. 2020 Nov;40(13):1474-1488. doi: 10.1177/0333102420940689. Epub 2020 Sep 22. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |