The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Danish Headache Center

Status: Completed

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Cilostazol; Drug: Sumatriptan

Study type: Interventional

Funder types: Other

Identifiers

NCT02486276

H-8-2014-009

Details and patient eligibility

About

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.

Full 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 this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: Cilostazol 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

Sumatriptan

Active Comparator group

Description:

headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg

Treatment:

Drug: Sumatriptan

Drug: Cilostazol

Placebo

Placebo Comparator group

Description:

headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo

Treatment:

Drug: Cilostazol

Drug: Placebo