PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

Migraine Without Aura Clinical Trial

Official title:

Investigation of PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881644
• Other study ID #: MigRosExperiment
• Status: Completed
• Phase: N/A
• Start date: July 17, 2018
• Est. completion date: December 7, 2019

Study information

• Verified date: June 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with migraine

Description:

Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. We are investigating whether treatment with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and migraine is induced.

The purpose of this study is to investigate PACAP38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The study will be conducted with a double-blind, placebo-controlled crossover study design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 7, 2019
• Est. primary completion date: December 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• diagnosis of migraine, according to IHS criteria

• weight between 50 - 100 kilograms

• women in fertile age must not be pregnant and must use adequate contraception

Exclusion Criteria:

• migraine more than 5 days per month in average over the past year

• any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month

• headache < 48 hours before experimental day

• migraine < 72 hours before each experimental day

• daily / frequent use of any medication apart from contraceptive medication

• use of any drug less than 5 times the half-life of the drug at the time of the experiment

• women who are pregnant or breast-feeding at the time of the experiment

• anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or

• diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)

• anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs

• patients with glaucoma or prostate hyperplasia

• anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study

Related Conditions & MeSH terms

• Flushing
• Headache
• Migraine Disorders
• Migraine without Aura

Intervention

Drug:
• Imigran
All patients will undergo this intervention on one of two study days

Other:
• Isotonic Saline
All patients will undergo this intervention on one of two study days
• Pituitary adenylate cyclase-activating peptide-38
All patients will undergo this intervention on both study days

Locations

Country	Name	City	State
Denmark	DanishHC	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of migraine	Incidence of migraine after PACAP38-infusion will be estimated through a standardized interview based on the international headache classification for migraine	From 0 to 12 hours after infusion
Primary	Effect of Sumatriptan	Severity of PACAP38-induced headache and migraine after pretreatment with sumatriptan in migraine patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")	From 0 to 12 hours after infusion
Secondary	Severity of flushing	Facial skin blood flow (flushing) will be measured by laser doppler flowmetry to evaluate the severity of PACAP38-induced flushing with and without sumatriptan-treatment	From 0 to 4 hours after infusion
Secondary	Facial temperature	PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography	From 0 to 4 hours after infusion
Secondary	Superficial temporal artery diameter	Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound	From 0 to 4 hours after infusion
Secondary	Severity of headache	Severity of PACAP38-induced headache will be rated on a numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")	From 0 to 12 hours after infusion