The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Drug: Cilostazol; Drug: Placebo; Drug: Sumatriptan

• Registration Number: NCT02486276
• Lead Sponsor: Danish Headache Center

Brief 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.

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 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo
Sumatriptan	Cilostazol	headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
Sumatriptan	Sumatriptan	headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg
Placebo	Cilostazol	headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo

Primary Outcome Measures

Name	Time	Method
Difference in median headache score 2 hours after sumatriptan/placebo	2 hours	The investigators will assess the outcome measures 1 year after the beginning of the study

Secondary Outcome Measures

Name	Time	Method
Area under the headache score curve	12 hours	The investigators will assess the outcome measures 1 year after the beginning of the study

Trial Locations

Locations (1)

Emma Katrine Hansen; 🇩🇰 Copenhagen, Glostrup, Denmark