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

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ClinicalTrials.gov Identifier: NCT03585894
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : February 12, 2019
Sponsor:
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 treated 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)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Sumatriptan
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)


Secondary Outcome Measures :
  1. Headache intensity [ Time Frame: 24 hours ]
    Visual analog Scale

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT03585894


Contacts
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Contact: Hashmat Ghanizada, MD 0045-51447278 hashmat.ghanizada@regionh.dk

Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Hashmat Ghanizada, MD    0045-51447278    hashmat.ghanizada@regionh.dk   
Sponsors and Collaborators
Danish Headache Center

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Responsible Party: Hashmat Ghanizada, Principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03585894     History of Changes
Other Study ID Numbers: H-18008313
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 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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Inflammation
Headache
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Sumatriptan
Pituitary Adenylate Cyclase-Activating Polypeptide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Growth Substances
Vasodilator Agents