Induction of Migraine Aura With Cilostazol

NCT ID: NCT02253004

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Migraine With Aura Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

Cilostazol 200 mg single dose

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Single oral administration of active or placebo one week apart

Placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Cilostazol

Single oral administration of active or placebo one week apart

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Pletal

Eligibility Criteria

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Inclusion Criteria

* Migraine with aura
* Minimum of 2 attacks/year

Exclusion Criteria

* Chronic tension type headache
* Cardiac arrhythmias
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christina Kruuse

Associate professor, consultant neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Kruuse, MD PhD DMSc

Role: PRINCIPAL_INVESTIGATOR

Consultant Neurologist, Dept Neurology

Locations

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Herlev Hospital, Dept Neurology

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2013-004188-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-3-2013-166

Identifier Type: -

Identifier Source: org_study_id

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