Back to resultsPretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Placebo
Sumatriptan
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.
Exclusion Criteria:
Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).
Sites / Locations
- Katrine Falkenberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sumatriptan
Placebo
Arm Description
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo
Outcomes
Primary Outcome Measures
Difference in median headache score 2 hours after cilostazol
The investigators will assess the outcome measures 1 year after the beginning of the study
Area under the headache score curve
The investigators will assess the outcome measures 1 year after the beginning of the study
Secondary Outcome Measures
Difference in peak headache score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03156920
Brief Title
Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
Official Title
Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
October 18, 2017 (Actual)
Study Completion Date
October 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. If the headache responds to sumatriptan, the model can be used to test new drug candidates.
Detailed Description
There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO).
To validate cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.
Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with a specific anti-migraine drug; sumatriptan.
Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sumatriptan
Arm Type
Active Comparator
Arm Description
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Intervention Description
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
Primary Outcome Measure Information:
Title
Difference in median headache score 2 hours after cilostazol
Description
The investigators will assess the outcome measures 1 year after the beginning of the study
Time Frame
2 hours
Title
Area under the headache score curve
Description
The investigators will assess the outcome measures 1 year after the beginning of the study
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Difference in peak headache score
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.
Exclusion Criteria:
Any type of headache (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).
Facility Information:
Facility Name
Katrine Falkenberg
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30120600
Citation
Falkenberg K, Olesen J. Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers. J Headache Pain. 2018 Aug 17;19(1):71. doi: 10.1186/s10194-018-0890-y.
Results Reference
derived
Learn more about this trial
Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
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