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Induction of Migraine Aura With Cilostazol

Primary Purpose

Migraine With Aura, Stroke

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Cilostazol
Placebo
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Migraine With Aura

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Migraine with aura
  • Minimum of 2 attacks/year

Exclusion Criteria:

  • Chronic tension type headache
  • Cardiac arrhythmias

Sites / Locations

  • Herlev Hospital, Dept Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Cilostazol 200 mg single dose

Placebo capsule

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Migraine
Induction of headache resembling usual migraine attacks
Endothelial response
Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol

Full Information

First Posted
September 26, 2014
Last Updated
August 20, 2015
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02253004
Brief Title
Induction of Migraine Aura With Cilostazol
Official Title
The Effect of the Selective PDE3 Inhibitor on Migraine With Aura Induction and Vascular Endothelial Function.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Stroke

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Cilostazol 200 mg single dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletal
Intervention Description
Single oral administration of active or placebo one week apart
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Aura
Description
Induction of aura reported by an aura diary for 24 hours post medication
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Migraine
Description
Induction of headache resembling usual migraine attacks
Time Frame
24 hours
Title
Endothelial response
Description
Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Migraine with aura Minimum of 2 attacks/year Exclusion Criteria: Chronic tension type headache Cardiac arrhythmias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Kruuse, MD PhD DMSc
Organizational Affiliation
Consultant Neurologist, Dept Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital, Dept Neurology
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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Induction of Migraine Aura With Cilostazol

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