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

NCT ID: NCT03585894

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-11-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will receive PACAP28 intravenous infusion over 20 min in both experiment days but treated in randomized order with sumatriptan or ketorolac.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sumatriptan

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

Group Type OTHER

Sumatriptan

Intervention Type OTHER

Receive intravenous infusion of sumatriptan

Ketorolac

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

Group Type ACTIVE_COMPARATOR

Ketorolac

Intervention Type OTHER

Receive intravenous infusion of ketorolac

Interventions

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Sumatriptan

Receive intravenous infusion of sumatriptan

Intervention Type OTHER

Ketorolac

Receive intravenous infusion of ketorolac

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Hashmat Ghanizada

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 32093617 (View on PubMed)

Other Identifiers

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H-18008313

Identifier Type: -

Identifier Source: org_study_id

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