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PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine

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ClinicalTrials.gov Identifier: NCT03881644
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nita Katarina Frifelt Wienholtz, Danish Headache Center

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
Migraine Without Aura Drug: Imigran Other: Isotonic Saline Other: Pituitary adenylate cyclase-activating peptide-38 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : July 17, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Sumatriptan

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 Name: Sumatriptan

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




Primary Outcome Measures :
  1. Incidence of migraine [ Time Frame: From 0 to 24 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 [ Time Frame: From 0 to 24 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From 0 to 24 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")



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881644


Contacts
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Contact: Nita KF Wienholtz, MD +45 38 63 46 12 nwie0008@regionh.dk

Locations
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Denmark
DanishHC Recruiting
Glostrup, Denmark, DK-2600
Contact: Nita KF Wienholtz, MD    +45 3863 4612    nwie0008@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
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Study Director: Messoud Ashina, MD,PhD,DMSc Danish Headache Center

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Responsible Party: Nita Katarina Frifelt Wienholtz, Principal Investigator, Medical Doctor, PhD Student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03881644     History of Changes
Other Study ID Numbers: MigRosExperiment
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sumatriptan
Migraine Disorders
Headache
Flushing
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Skin Manifestations
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents