Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

Migraine Clinical Trial

Official title:

Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156920
• Other study ID #: H-15011960
• Status: Completed
• Phase: N/A
• First received: May 10, 2017
• Last updated: October 18, 2017
• Start date: May 23, 2017
• Est. completion date: October 18, 2017

Study information

• Verified date: October 2017
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	Katrine Falkenberg	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in median headache score 2 hours after cilostazol	The investigators will assess the outcome measures 1 year after the beginning of the study	2 hours
Primary	Area under the headache score curve	The investigators will assess the outcome measures 1 year after the beginning of the study	12 hours
Secondary	Difference in peak headache score		12 hours