Induction of Migraine Aura With Cilostazol | NCT02253004

Studies
Induction of Migraine Aura With Cilostazol

NCT02253004

Sponsor

Herlev Hospital

Status

Completed

Last Update Posted

Aug 21, 2015Estimated

Enrollment

16Actual

Phase

Early Phase 1

Conditions

Migraine With Aura
Stroke

Interventions

Cilostazol
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-004188-29	EudraCT Number

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 26, 2014

First Submission Date that Met QC Criteria

Sep 30, 2014

First Posted Date

Oct 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2015

Last Update Posted Date

Aug 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Cilostazol 200 mg single dose	Drug: Cilostazol
Placebo	Placebo Comparator	Placebo capsule	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cilostazol	Drug	Single oral administration of active or placebo one week apart	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aura	Induction of aura reported by an aura diary for 24 hours post medication	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Migraine	Induction of headache resembling usual migraine attacks	24 hours
Endothelial response	Measurement of endothelial response by Endopat2000 before and after administration of placebo and cilostazol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Migraine with aura
Minimum of 2 attacks/year

Exclusion Criteria:

Chronic tension type headache
Cardiac arrhythmias

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Kruuse, MD PhD DMSc	Consultant Neurologist, Dept Neurology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Hospital, Dept Neurology		Herlev		2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020325	Migraine with Aura
D020521	Stroke

Ancestor Terms

ID	Term
D008881	Migraine Disorders
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077407	Cilostazol

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided