Back to resultsThe Headache Inducing Effects of Cilostazol on Migraine Patients
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cilostazol
Placebo
Sponsored by
About this trial
This is an interventional health services research trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with migraine without aura according to the IHS criteria from 2004.
- Healthy besides migraine
Exclusion Criteria:
- Tension-type headache more than 3 days per month
- Other types of primary headaches
- Pregnancy
- History of vascular diseases or psychiatric diseases.
Sites / Locations
- Danish Headache Center & Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cilostazol
Placebo
Arm Description
Capsule of Cilostazol 200 mg are taken orally on each study day
A capsule of placebo containing starch are taken orally on each study day.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01841827
Brief Title
The Headache Inducing Effects of Cilostazol on Migraine Patients
Official Title
The Headache Inducing Effects of Cilostazol on Migraine Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We will use Cilostazol as a tool to investigate its headache inducing effects in migraine patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cilostazol
Arm Type
Active Comparator
Arm Description
Capsule of Cilostazol 200 mg are taken orally on each study day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A capsule of placebo containing starch are taken orally on each study day.
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletal
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The incidens of headache or migraine after adminstration of Cilostazol in migraine patients compared to placebo.
Description
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.
Time Frame
Outcome measure will be done within 3 month. Final data will be presented within 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with migraine without aura according to the IHS criteria from 2004.
Healthy besides migraine
Exclusion Criteria:
Tension-type headache more than 3 days per month
Other types of primary headaches
Pregnancy
History of vascular diseases or psychiatric diseases.
Facility Information:
Facility Name
Danish Headache Center & Department of Neurology
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Headache Inducing Effects of Cilostazol on Migraine Patients
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