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PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT03881644
Collaborator
(none)
37
Enrollment
1
Location
2
Arms
16.7
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Imigran
  • Other: Isotonic Saline
  • Other: Pituitary adenylate cyclase-activating peptide-38
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Investigation of PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine
Actual Study Start Date :
Jul 17, 2018
Actual Primary Completion Date :
Dec 7, 2019
Actual Study Completion Date :
Dec 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

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

    • Other: Pituitary adenylate cyclase-activating peptide-38
    All patients will undergo this intervention on both study days
    Other Names:
  • PACAP38

    		•
    Placebo Comparator: PACAP38 + Isotonic Saline

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

    Other: Isotonic Saline
    All patients will undergo this intervention on one of two study days

    Other: Pituitary adenylate cyclase-activating peptide-38
    All patients will undergo this intervention on both study days
    Other Names:
  • PACAP38

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of migraine [From 0 to 12 hours after infusion]

      Incidence of migraine after PACAP38-infusion will be estimated through a standardized interview based on the international headache classification for migraine

    2. Effect of Sumatriptan [From 0 to 12 hours after infusion]

      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")

    Secondary Outcome Measures

    1. Severity of flushing [From 0 to 4 hours after infusion]

      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

    2. Facial temperature [From 0 to 4 hours after infusion]

      PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography

    3. Superficial temporal artery diameter [From 0 to 4 hours after infusion]

      Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound

    4. Severity of headache [From 0 to 12 hours after infusion]

      Severity of PACAP38-induced headache will be rated on a numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DanishHC Glostrup Denmark DK-2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    • Study Director: Messoud Ashina, MD,PhD,DMSc, Danish Headache Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nita Katarina Frifelt Wienholtz, Principal Investigator, Medical Doctor, PhD Student, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT03881644
    Other Study ID Numbers:
    • MigRosExperiment
    First Posted:
    Mar 19, 2019
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Migraine Disorders
    Migraine without Aura
    Headache
    Flushing
    Sumatriptan
    Pituitary Adenylate Cyclase-Activating Polypeptide

    Study Results

    No Results Posted as of Jun 22, 2020