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NCT02253004 Clinical Trial

Induction of Migraine Aura With Cilostazol

Stroke Clinical Trial

Official title:
The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02253004
Other study ID # H-3-2013-166
Secondary ID 2013-004188-29
Status Completed
Phase Phase 0
First received September 26, 2014
Last updated August 20, 2015
Start date September 2014
Est. completion date August 2015

Study information
Verified date August 2015
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Migraine with aura

- Minimum of 2 attacks/year

Exclusion Criteria:

- Chronic tension type headache

- Cardiac arrhythmias

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Cilostazol
Single oral administration of active or placebo one week apart
• Placebo

Locations
Country Name City State
Denmark Herlev Hospital, Dept Neurology Herlev

Sponsors (1)
Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aura Induction of aura reported by an aura diary for 24 hours post medication 24 hours No
Secondary Migraine Induction of headache resembling usual migraine attacks 24 hours No
Secondary Endothelial response Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol 3 hours No
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