Migraine Without Aura
Conditions
Brief summary
The aim is to investigate the incidence of headache, migraine attacks and flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with migraine
Detailed description
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in migraine pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in some migraine patients and will induce flushing in all patients. We are investigating whether treatment with sumatriptan has an effect on the PACAP38-induced flushing and on whether headache and migraine is induced. The purpose of this study is to investigate PACAP38-induced headache and migraine in patients with migraine who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The study will be conducted with a double-blind, placebo-controlled crossover study design.
Interventions
DRUGImigran
All patients will undergo this intervention on one of two study days
OTHERIsotonic Saline
All patients will undergo this intervention on one of two study days
OTHERPituitary adenylate cyclase-activating peptide-38
All patients will undergo this intervention on both study days
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of migraine, according to IHS criteria * weight between 50 - 100 kilograms * women in fertile age must not be pregnant and must use adequate contraception
Exclusion criteria
* migraine more than 5 days per month in average over the past year * any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month * headache \< 48 hours before experimental day * migraine \< 72 hours before each experimental day * daily / frequent use of any medication apart from contraceptive medication * use of any drug less than 5 times the half-life of the drug at the time of the experiment * women who are pregnant or breast-feeding at the time of the experiment * anamnestic or clinical signs of hypertension (systolic blood pressure \> 150 mmHg and/or * diastolic blood pressure \> 100 mmHg) or hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg) * anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs * patients with glaucoma or prostate hyperplasia * anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of migraine | From 0 to 12 hours after infusion | Incidence of migraine after PACAP38-infusion will be estimated through a standardized interview based on the international headache classification for migraine |
| Effect of Sumatriptan | From 0 to 12 hours after infusion | Severity of PACAP38-induced headache and migraine after pretreatment with sumatriptan in migraine patients measured by numerical rating scale for pain from 0 (no pain) to 10 (worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of flushing | From 0 to 4 hours after infusion | Facial skin blood flow (flushing) will be measured by laser doppler flowmetry to evaluate the severity of PACAP38-induced flushing with and without sumatriptan-treatment |
| Facial temperature | From 0 to 4 hours after infusion | PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography |
| Superficial temporal artery diameter | From 0 to 4 hours after infusion | Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound |
| Severity of headache | From 0 to 12 hours after infusion | Severity of PACAP38-induced headache will be rated on a numerical rating scale for pain from 0 (no pain) to 10 (worst pain imaginable) |
Countries
Denmark
Outcome results
None listed