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The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Information source: Danish Headache Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: Cilostazol (Drug); Sumatriptan (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Danish Headache Center

Official(s) and/or principal investigator(s):
Emma Katrine Hansen, Doctor, Principal Investigator, Affiliation: Danish Headache Center

Overall contact:
Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Median headache score 0 hours after sumatriptan/placebo

Median headache score 2 hours after sumatriptan/placebo

Secondary outcome: Area under the headache score curve (12 hours after cilostazol)

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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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)

Locations and Contacts

Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk

Emma Katrine Hansen, Copenhagen, Glostrup 2600, Denmark; Recruiting
Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk
Additional Information

Starting date: June 2015
Last updated: June 26, 2015

Page last updated: August 23, 2015

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