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Induction of Migraine Aura With Cilostazol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02253004
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : August 21, 2015
Information provided by (Responsible Party):
Christina Kruuse, Herlev Hospital

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
Migraine With Aura Stroke Drug: Cilostazol Drug: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Cilostazol

Arm Intervention/treatment
Experimental: Active
Cilostazol 200 mg single dose
Drug: Cilostazol
Single oral administration of active or placebo one week apart
Other Name: Pletal

Placebo Comparator: Placebo
Placebo capsule
Drug: Placebo

Primary Outcome Measures :
  1. Aura [ Time Frame: 24 hours ]
    Induction of aura reported by an aura diary for 24 hours post medication

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02253004

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Herlev Hospital, Dept Neurology
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
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Principal Investigator: Christina Kruuse, MD PhD DMSc Consultant Neurologist, Dept Neurology

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Responsible Party: Christina Kruuse, Associate professor, consultant neurologist, Herlev Hospital Identifier: NCT02253004     History of Changes
Other Study ID Numbers: H-3-2013-166
2013-004188-29 ( EudraCT Number )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors