Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danish Headache Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Difference in median headache score 2 hours after cilostazol
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
Sumatriptan
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg
Intervention: Sumatriptan (Drug)
Placebo
Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Difference in peak headache score(12 hours)
Investigators
Katrine Falkenberg
Medical doctor, PhD student, principal investigator
Danish Headache Center