Migraine
Conditions
Brief summary
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug candidates.
Detailed description
There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan. Hypothesis: 5-ISMN induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan. Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs
Interventions
DRUG5-ISMN (isosorbide-5-mononitrate)
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
DRUGSumatriptan
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
DRUGPlacebo
5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy: * healthy subjects of both sexes * age 18-70 years * weight 50-90 kg. * Females were requested to use effective contraception. Migraine patients: * Migraine patients who meet International headache society (IHS) criteria for migraine with or without aura of both sexes * 18-70 years * 45-95 kg.
Exclusion criteria
Healthy: * Any type of headache (except episodic tension-type headache \< 1 day per week) * Serious somatic or psychiatric disease * Pregnancy * Intake of daily medication (except oral contraceptives). Migraine patients: * Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) * Serious somatic or psychiatric disease * Pregnancy, and intake of daily medication (except oral contraceptives).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median headache score 0 hours after sumatriptan/placebo | 0 hours |
| Median headache score 2 hours after sumatriptan/placebo | 2 hours |
Countries
Denmark
Outcome results
None listed