NCT01841827

Brief Summary

We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

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

April 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

April 20, 2013

Last Update Submit

June 5, 2014

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo.

    Rectruitment of 14 patients will be done during April and May. Experiments will be carried out in May and June. Each experiment day takes 1½ hour. Data analysis will be done in June and July. Final data will be presented within 6 months.

    Outcome measure will be done within 3 month. Final data will be presented within 6 months

Study Arms (2)

Cilostazol

ACTIVE COMPARATOR

Capsule of Cilostazol 200 mg are taken orally on each study day

Drug: Cilostazol

Placebo

PLACEBO COMPARATOR

A capsule of placebo containing starch are taken orally on each study day.

Drug: Placebo

Interventions

CilostazolDRUG
Also known as: Pletal
Cilostazol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with migraine without aura according to the IHS criteria from 2004.
  • Healthy besides migraine

You may not qualify if:

  • Tension-type headache more than 3 days per month
  • Other types of primary headaches
  • Pregnancy
  • History of vascular diseases or psychiatric diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center & Department of Neurology

Copenhagen, Glostrup, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 20, 2013

First Posted

April 29, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

DK(1)