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The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT02486276
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Sumatriptan

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

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

    • 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
    Other Names:
  • Imigran

    		•
    Placebo Comparator: Placebo

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

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

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. Difference in median headache score 2 hours after sumatriptan/placebo [2 hours]

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

    Secondary Outcome Measures

    1. Area under the headache score curve [12 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emma Katrine Hansen Copenhagen Glostrup Denmark 2600

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    • Principal Investigator: Emma Katrine Hansen, Doctor, Danish Headache Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emma Katrine Hansen, Medical doctor, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT02486276
    Other Study ID Numbers:
    • H-8-2014-009
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    Additional relevant MeSH terms:
    Migraine Disorders
    Headache
    Cilostazol
    Sumatriptan

    Study Results

    No Results Posted as of May 9, 2017