Induction of Migraine Aura With Cilostazol

Early Phase 1

Completed

• Conditions: Migraine With Aura; Stroke
• Interventions: Drug: Placebo; Drug: Cilostazol

• Registration Number: NCT02253004
• Lead Sponsor: Herlev Hospital

Brief Summary

In a double blind placebo-controlled cross-over study the effect of cilostazol on aura induction and endothelial response is tested in patient with migraine with aura.

Detailed Description

Migraine with aura is associated to an increased risk of stroke. The mechanism behind such increased risk is not fully understood. Cilostazol induce headache and migraine in migraine patients and is used as secondary prevention of stroke. The effect on aura induction is not known. We investigate the aura inducing potential of cilostazol and associated changes in endothelial function.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-01
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Migraine with aura
• Minimum of 2 attacks/year

Exclusion Criteria

• Chronic tension type headache
• Cardiac arrhythmias

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo capsule
Active	Cilostazol	Cilostazol 200 mg single dose

Primary Outcome Measures

Name	Time	Method
Aura	24 hours	Induction of aura reported by an aura diary for 24 hours post medication

Secondary Outcome Measures

Name	Time	Method
Migraine	24 hours	Induction of headache resembling usual migraine attacks
Endothelial response	3 hours	Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol

Trial Locations

Locations (1)

Herlev Hospital, Dept Neurology; 🇩🇰 Herlev, Denmark