Headache
Conditions
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.
Interventions
OTHERSumatriptan
Receive intravenous infusion of sumatriptan
OTHERKetorolac
Receive intravenous infusion of ketorolac
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 2 hours | vital parameters recorded at hospital phase |
| Headache characteristics | 24 hours | Standard headache questionnaire will be used to record headache localization, nausea, photo and phonophobia. |
| Heart rate | 2 hours | vital parameters recorded at hospital phase |
Countries
Denmark
Outcome results
None listed