The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model

Sponsors

Lead Sponsor: Danish Headache Center

Source Danish Headache Center
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.

Overall Status Completed
Start Date June 2015
Completion Date June 2016
Primary Completion Date June 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Difference in median headache score 2 hours after sumatriptan/placebo 2 hours
Secondary Outcome
Measure Time Frame
Area under the headache score curve 12 hours
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cilostazol

Description: Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Other Name: Pletal

Intervention Type: Drug

Intervention Name: Sumatriptan

Description: Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Arm Group Label: Sumatriptan

Other Name: Imigran

Intervention Type: Drug

Intervention Name: Placebo

Description: Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Arm Group Label: Placebo

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Emma Katrine Hansen, Doctor Principal Investigator Danish Headache Center
Location
Facility: Emma Katrine Hansen
Location Countries

Denmark

Verification Date

May 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Danish Headache Center

Investigator Full Name: Emma Katrine Hansen

Investigator Title: Medical doctor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Sumatriptan

Type: Active Comparator

Description: headache is induced with Cilostazol. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg

Label: Placebo

Type: Placebo Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov