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Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

NCT ID: NCT03156920

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-23

Study Completion Date

2017-10-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sumatriptan

Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg

Group Type ACTIVE_COMPARATOR

Sumatriptan

Intervention Type DRUG

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

Placebo

Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Sumatriptan

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

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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Katrine Falkenberg

Medical doctor, PhD student, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Katrine Falkenberg

Copenhagen, Glostrup, Denmark

Site Status

Countries

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Denmark

References

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Falkenberg K, Olesen J. Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers. J Headache Pain. 2018 Aug 17;19(1):71. doi: 10.1186/s10194-018-0890-y.

Reference Type DERIVED
PMID: 30120600 (View on PubMed)

Other Identifiers

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H-15011960

Identifier Type: -

Identifier Source: org_study_id