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

Not Applicable

Completed

• Conditions: Headache
• Interventions: Other: Sumatriptan; Other: Ketorolac

• Registration Number: NCT03585894
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-13
• Study Start: 2018-08-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-11-25
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-29
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sumatriptan	Sumatriptan	Sumatriptan 4 mg/mL I.V will be administrated over 10 min
Ketorolac	Ketorolac	Ketorolac 30 mg/mL I.V will be administrated over 10 min

Primary Outcome Measures

Name	Time	Method
Intra-extra cerebral arteries vasodilatation	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)
Headache score	6 hours	Visual analog Scale

Secondary Outcome Measures

Name	Time	Method
Headache characteristics	24 hours	Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia.
Blood pressure	2 hours	vital parameters recorded at hospital phase
Heart rate	2 hours	vital parameters recorded at hospital phase

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark