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The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03585894
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : January 2, 2020
Information provided by (Responsible Party):
Hashmat Ghanizada, Danish Headache Center

Brief Summary:
Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac assessed by magnetic resonance imaging (MRI) on healthy volunteers.

Condition or disease Intervention/treatment Phase
Headache Other: Sumatriptan Other: Ketorolac Not Applicable

Detailed Description:
The purpose of this research project is to investigate the importance of blood vessel (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac (NSAID). In addition, we will investigate headache-related changes in the brain's network connectivity.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each participant will receive PACAP28 intravenous infusion over 20 min in both experiment days but treated in randomized order with sumatriptan or ketorolac.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : November 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Sumatriptan 4 mg/mL I.V will be administrated over 10 min
Other: Sumatriptan
Receive intravenous infusion of sumatriptan

Active Comparator: Ketorolac
Ketorolac 30 mg/mL I.V will be administrated over 10 min
Other: Ketorolac
Receive intravenous infusion of ketorolac

Primary Outcome Measures :
  1. Intra-extra cerebral arteries vasodilatation [ Time Frame: 120 minutes ]
    PACAP38 vasodilatation reverse by sumatriptan but not ketorolac. A single-slab 3D time-of-flight (3D TOF) MRA of extra- and intracranial arteries will be acquired as described in previous studies (Amin et al., 2013, 2014). MRA data will be analyzed by LKEB-MRA vessel wall analysis software program. We will measure the circumference of vessels in millimeter in 4 predefined time points (0, 20, 60 and 110 min)

  2. Headache score [ Time Frame: 6 hours ]
    Visual analog Scale

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 2 hours ]
    vital parameters recorded at hospital phase

  2. Headache characteristics [ Time Frame: 24 hours ]
    Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia.

  3. Heart rate [ Time Frame: 2 hours ]
    vital parameters recorded at hospital phase

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy volunteers
  • Aged 18-50
  • 50-100 kg

Exclusion Criteria:

  • Tension type headache more than 5 dag /month
  • Other primary headaches
  • Daily medication except contraceptives
  • Drug taken within 4 times the half-life for the specific drug except contraceptives
  • Pregnant or lactating women
  • Exposure to radiation within the last year
  • Headache within the last 24 hours before start of trial
  • Hypertension
  • Hypotension
  • Respiratory or cardiac disease
  • Primary relatives with current or previous migraine

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 identifier (NCT number): NCT03585894

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Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hashmat Ghanizada, Principal investigator, Danish Headache Center Identifier: NCT03585894    
Other Study ID Numbers: H-18008313
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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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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Pathologic Processes
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents