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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585894
• Other study ID #: H-18008313
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: November 25, 2019

Study information

• Verified date: December 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 25, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Inflammation

Intervention

Other:
• Sumatriptan
Receive intravenous infusion of sumatriptan
• Ketorolac
Receive intravenous infusion of ketorolac

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Headache score	Visual analog Scale	6 hours
Secondary	Blood pressure	vital parameters recorded at hospital phase	2 hours
Secondary	Headache characteristics	Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia.	24 hours
Secondary	Heart rate	vital parameters recorded at hospital phase	2 hours