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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