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Completed

NCT Number: NCT03156920

Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Katrine Falkenberg

Copenhagen, Glostrup, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Placebo

Drug

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

Sumatriptan

Drug

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

Primary outcomes

  1. Difference in median headache score 2 hours after cilostazol

    Time frame: 2 hours

    The investigators will assess the outcome measures 1 year after the beginning of the study

  2. Area under the headache score curve

    Time frame: 12 hours

    The investigators will assess the outcome measures 1 year after the beginning of the study

Secondary outcomes

  1. Difference in peak headache score

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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