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The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cilostazol
Sumatriptan
Placebo
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Healthy:

  • Healthy subjects of both sexes
  • Age 18-70 years
  • Weight 50-90 kg.
  • Females were requested to use effective contraception.

Migraine patients:

  • Migraine patients who meet IHS criteria for migraine with or without aura of both sexes
  • 18-70 years
  • 45-95 kg.

Exclusion Criteria:

Healthy:

  • 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).

Migraine patients:

  • Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week)
  • Serious somatic or psychiatric disease
  • Pregnancy
  • Intake of daily medication (except oral contraceptives)

Sites / Locations

  • Emma Katrine Hansen

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 treated double-blinded with 1 tablet of sumatriptan 50 mg

headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo

Outcomes

Primary Outcome Measures

Difference in median headache score 2 hours after sumatriptan/placebo
The investigators will assess the outcome measures 1 year after the beginning of the study

Secondary Outcome Measures

Area under the headache score curve
The investigators will assess the outcome measures 1 year after the beginning of the study

Full Information

First Posted
June 4, 2015
Last Updated
May 8, 2017
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT02486276
Brief Title
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache
Official Title
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (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
To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with a phosphodiesterase inhibitor (cilostazol). 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 this model, the headache must respond to specific migraine treatment with sumatriptan. Hypothesis: Cilostazol induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to 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 treated double-blinded with 1 tablet of sumatriptan 50 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of placebo
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletal
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
Other Intervention Name(s)
Imigran
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)
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
Primary Outcome Measure Information:
Title
Difference in median headache score 2 hours after sumatriptan/placebo
Description
The investigators will assess the outcome measures 1 year after the beginning of the study
Time Frame
2 hours
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy: Healthy subjects of both sexes Age 18-70 years Weight 50-90 kg. Females were requested to use effective contraception. Migraine patients: Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-70 years 45-95 kg. Exclusion Criteria: Healthy: 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). Migraine patients: Any other type of headache then migraine without aura (except episodic tension-type headache < 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Katrine Hansen, Doctor
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emma Katrine Hansen
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29396788
Citation
Falkenberg K, Dunga BOA, Guo S, Ashina M, Olesen J. Cilostazol induced migraine does not respond to sumatriptan in a double blind trial. J Headache Pain. 2018 Feb 2;19(1):11. doi: 10.1186/s10194-018-0841-7.
Results Reference
derived

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The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

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