NCT02253004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2014

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

September 26, 2014

Last Update Submit

August 20, 2015

Conditions

Migraine With AuraStroke

Outcome Measures

Primary Outcomes (1)

  • Aura

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

    24 hours

Secondary Outcomes (2)

  • Migraine

    24 hours

  • Endothelial response

    3 hours

Study Arms (2)

Active

EXPERIMENTAL

Cilostazol 200 mg single dose

Drug: Cilostazol

Placebo

PLACEBO COMPARATOR

Placebo capsule

Drug: Placebo

Interventions

CilostazolDRUG

Single oral administration of active or placebo one week apart

Also known as: Pletal
Active
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Migraine with aura
  • Minimum of 2 attacks/year

You may not qualify if:

  • Chronic tension type headache
  • Cardiac arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital, Dept Neurology

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Migraine with AuraStroke

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Christina Kruuse, MD PhD DMSc

    Consultant Neurologist, Dept Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, consultant neurologist

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 1, 2014

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

DK(1)