Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
- Registration Number
- NCT03156920
- Lead Sponsor
- Danish Headache Center
- Brief Summary
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. 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 Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO).
To validate cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with a specific anti-migraine drug; sumatriptan.
Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo Sumatriptan Sumatriptan Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
- Primary Outcome Measures
Name Time Method Difference in median headache score 2 hours after cilostazol 2 hours The investigators will assess the outcome measures 1 year after the beginning of the study
Area under the headache score curve 12 hours The investigators will assess the outcome measures 1 year after the beginning of the study
- Secondary Outcome Measures
Name Time Method Difference in peak headache score 12 hours
Trial Locations
- Locations (1)
Katrine Falkenberg
🇩🇰Copenhagen, Glostrup, Denmark