The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Danish Headache Center

Status: Completed

Conditions: Migraine

Treatments: Drug: Cilostazol 200mg; Drug: SUMAtriptan 6 MG/ML; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03422796

H-17026731

Details and patient eligibility

About

To develop a pragmatic migraine model the investigators will induce headache in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). If the headache responds to sumatriptan injection, 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 MO-patients and the induced headache responds to sumatriptan injection Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
• 18-70 years
• 45-95 kg.

Exclusion criteria

• 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)
• Triptan non-responders

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 6mg/ml sumatriptan

Treatment:

Drug: SUMAtriptan 6 MG/ML

Drug: Cilostazol 200mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Cilostazol 200mg