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

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sumatriptan
Ketorolac
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Sumatriptan

Ketorolac

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
Headache score
Visual analog Scale

Secondary Outcome Measures

Blood pressure
vital parameters recorded at hospital phase
Headache characteristics
Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia.
Heart rate
vital parameters recorded at hospital phase

Full Information

First Posted
June 28, 2018
Last Updated
December 29, 2019
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT03585894
Brief Title
The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Official Title
The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sumatriptan
Arm Type
Other
Arm Description
Sumatriptan 4 mg/mL I.V will be administrated over 10 min
Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Ketorolac 30 mg/mL I.V will be administrated over 10 min
Intervention Type
Other
Intervention Name(s)
Sumatriptan
Intervention Description
Receive intravenous infusion of sumatriptan
Intervention Type
Other
Intervention Name(s)
Ketorolac
Intervention Description
Receive intravenous infusion of ketorolac
Primary Outcome Measure Information:
Title
Intra-extra cerebral arteries vasodilatation
Description
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)
Time Frame
120 minutes
Title
Headache score
Description
Visual analog Scale
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Blood pressure
Description
vital parameters recorded at hospital phase
Time Frame
2 hours
Title
Headache characteristics
Description
Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia.
Time Frame
24 hours
Title
Heart rate
Description
vital parameters recorded at hospital phase
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
32093617
Citation
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.
Results Reference
derived

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

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