Clinical trial NCT03881644: PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Official title: Investigation of PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of migraine
timeFrame: From 0 to 12 hours after infusion
measure: Effect of Sumatriptan
timeFrame: From 0 to 12 hours after infusion
Secondary outcomes:
measure: Severity of flushing
timeFrame: From 0 to 4 hours after infusion
measure: Facial temperature
timeFrame: From 0 to 4 hours after infusion
measure: Superficial temporal artery diameter
timeFrame: From 0 to 4 hours after infusion
measure: Severity of headache
timeFrame: From 0 to 12 hours after infusion
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: DanishHC
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina, MD,PhD,DMSc
role: STUDY_DIRECTOR
References:
citation: Wienholtz NKF, Christensen CE, Zhang DG, Coskun H, Ghanizada H, Al-Karagholi MA, Hannibal J, Egeberg A, Thyssen JP, Ashina M. Early treatment with sumatriptan prevents PACAP38-induced migraine: A randomised clinical trial. Cephalalgia. 2021 May;41(6):731-748. doi: 10.1177/0333102420975395. Epub 2021 Feb 10.