Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

Overview

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.

Full Title of Study: “Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 18, 2017

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 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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Active Comparator: Sumatriptan
    • Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
  • Placebo Comparator: Placebo
    • Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • Difference in peak headache score
    • Time Frame: 12 hours

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Danish Headache Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Katrine Falkenberg, Medical doctor, PhD student, principal investigator – Danish Headache Center

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