PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

NCT ID: NCT03881644

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2019-12-07

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.

Conditions

Migraine Without Aura

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PACAP38 + Imigran

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins

AND

Imigran infusion (0.4 mg/min) for 10 mins

Group Type: ACTIVE_COMPARATOR

Imigran

Intervention Type: DRUG

All patients will undergo this intervention on one of two study days

Pituitary adenylate cyclase-activating peptide-38

Intervention Type: OTHER

All patients will undergo this intervention on both study days

PACAP38 + Isotonic Saline

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins

AND

Isotonic saline for 10 mins (placebo)

Group Type: PLACEBO_COMPARATOR

Isotonic Saline

Intervention Type: OTHER

All patients will undergo this intervention on one of two study days

Pituitary adenylate cyclase-activating peptide-38

Intervention Type: OTHER

All patients will undergo this intervention on both study days

Interventions

Imigran

All patients will undergo this intervention on one of two study days

Intervention Type: DRUG

Isotonic Saline

All patients will undergo this intervention on one of two study days

Intervention Type: OTHER

Pituitary adenylate cyclase-activating peptide-38

All patients will undergo this intervention on both study days

Intervention Type: OTHER

Other Intervention Names

Sumatriptan; PACAP38

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Nita Katarina Frifelt Wienholtz

Principal Investigator, Medical Doctor, PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Messoud Ashina, MD,PhD,DMSc

Role: STUDY_DIRECTOR

Danish Headache Center

Locations

DanishHC

Glostrup Municipality, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 33567890 (View on PubMed)

Other Identifiers

MigRosExperiment

Identifier Type: -

Identifier Source: org_study_id