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

NCT03585894 | Completed DMC

• 1 other identifier: H-18008313
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (2)

• Intra-extra cerebral arteries vasodilatation

  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)

  120 minutes

• Headache score

  Visual analog Scale

  6 hours

Secondary Outcomes (3)

• Blood pressure

  2 hours

• Headache characteristics

  24 hours

• Heart rate

  2 hours

Study Arms (2)

Sumatriptan

OTHER

Sumatriptan 4 mg/mL I.V will be administrated over 10 min

Other: Sumatriptan

Ketorolac

ACTIVE COMPARATOR

Ketorolac 30 mg/mL I.V will be administrated over 10 min

Other: Ketorolac

Interventions

Sumatriptan OTHER

Receive intravenous infusion of sumatriptan

Sumatriptan

Ketorolac OTHER

Receive intravenous infusion of ketorolac

Ketorolac

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Aged 18-50

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Metcalf-Clausen M, Larsson HBW, Amin FM, Ashina M. Investigation of sumatriptan and ketorolac trometamol in the human experimental model of headache. J Headache Pain. 2020 Feb 24;21(1):19. doi: 10.1186/s10194-020-01089-3.

  PMID: 32093617 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Sumatriptan; Ketorolac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Indomethacin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Each participant will receive PACAP28 intravenous infusion over 20 min in both experiment days but treated in randomized order with sumatriptan or ketorolac.

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 13, 2018
• Study Start: August 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: November 25, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

DK (1)