Overview

The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Danish Headache Center
Treatments:
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)