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Induction of Migraine Aura With Cilostazol

Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02253004
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
11
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active

Cilostazol 200 mg single dose

Drug: Cilostazol
Single oral administration of active or placebo one week apart
Other Names:
  • Pletal

    		•
    Placebo Comparator: Placebo

    Placebo capsule

    Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Aura [24 hours]

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

    Secondary Outcome Measures

    1. Migraine [24 hours]

      Induction of headache resembling usual migraine attacks

    2. Endothelial response [3 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Migraine with aura

    • Minimum of 2 attacks/year

    Exclusion Criteria:

    • Chronic tension type headache

    • Cardiac arrhythmias

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Herlev Hospital, Dept Neurology Herlev Denmark 2730

    Sponsors and Collaborators

    • Herlev Hospital

    Investigators

    • Principal Investigator: Christina Kruuse, MD PhD DMSc, Consultant Neurologist, Dept Neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christina Kruuse, Associate professor, consultant neurologist, Herlev Hospital
    ClinicalTrials.gov Identifier:
    NCT02253004
    Other Study ID Numbers:
    • H-3-2013-166
    • 2013-004188-29
    First Posted:
    Oct 1, 2014
    Last Update Posted:
    Aug 21, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Migraine Disorders
    Migraine with Aura
    Cilostazol

    Study Results

    No Results Posted as of Aug 21, 2015