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Induction of Migraine Aura With Cilostazol

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02253004
Enrollment
16
Registered
2014-10-01
Start date
2014-09-30
Completion date
2015-08-31
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine With Aura, Stroke

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.

Interventions

DRUGCilostazol

Single oral administration of active or placebo one week apart

DRUGPlacebo

Sponsors

Herlev Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Migraine with aura * Minimum of 2 attacks/year

Exclusion criteria

* Chronic tension type headache * Cardiac arrhythmias

Design outcomes

Primary

MeasureTime frameDescription
Aura24 hoursInduction of aura reported by an aura diary for 24 hours post medication

Secondary

MeasureTime frameDescription
Migraine24 hoursInduction of headache resembling usual migraine attacks
Endothelial response3 hoursMeasurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026