The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Drug: Cilostazol 200mg; Drug: SUMAtriptan 6 MG/ML; Drug: Placebo

• Registration Number: NCT03422796
• Lead Sponsor: Danish Headache Center

Brief Summary

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.

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 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.

Study Timeline

• Study First Submitted: 2017-10-20
• Study Start: 2017-11-01
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sumatriptan	Cilostazol 200mg	headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
Sumatriptan	SUMAtriptan 6 MG/ML	headache is induced with Cilostazol. This headache is treated double-blinded with 6mg/ml sumatriptan
Placebo	Cilostazol 200mg	headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb
Placebo	Placebo	headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placeb

Primary Outcome Measures

Name	Time	Method
difference in AUC 0-4h post treatment	4hours	The difference in area under the curve 0-4h after treatment with sumatriptan and placebo
Difference in median headache score after sumatriptan/placebo	2hours	The investigators will assess the outcome measures 1 year after the beginning of the study

Trial Locations

Locations (1)

Rigshospitalet Glostrup; 🇩🇰 Glostrup, Denmark