Overview
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache
Status:
Completed
Completed
Trial end date:
2016-06-01
2016-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan, the model can be used to test new drug candidates.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Danish Headache CenterTreatments:
Cilostazol
Sumatriptan
Criteria
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 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
- Intake of daily medication (except oral contraceptives)