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Completed

NCT Number: NCT02253004

Induction of Migraine Aura With Cilostazol

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.

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Key information

Conditions

Migraine With Aura Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Herlev Hospital, Dept Neurology

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Migraine with aura
  • Minimum of 2 attacks/year

Exclusion criteria

  • Chronic tension type headache
  • Cardiac arrhythmias

Treatment and study plan

Cilostazol

Drug

Single oral administration of active or placebo one week apart

Other names: Pletal

Placebo

Drug

Primary outcomes

  1. Aura

    Time frame: 24 hours

    Induction of aura reported by an aura diary for 24 hours post medication

Secondary outcomes

  1. Migraine

    Time frame: 24 hours

    Induction of headache resembling usual migraine attacks

  2. Endothelial response

    Time frame: 3 hours

    Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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