The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache
Information source: Danish Headache Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Cilostazol (Drug); Sumatriptan (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Danish Headache Center Official(s) and/or principal investigator(s): Emma Katrine Hansen, Doctor, Principal Investigator, Affiliation: Danish Headache Center
Overall contact: Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk
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.
Clinical Details
Official title: The Effect of Sumatriptan and Placebo on Cilostazol Induced Headache. Development of a Pragmatic Migraine Model
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Median headache score 0 hours after sumatriptan/placeboMedian headache score 2 hours after sumatriptan/placebo
Secondary outcome: Area under the headache score curve (12 hours after cilostazol)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk
Emma Katrine Hansen, Copenhagen, Glostrup 2600, Denmark; Recruiting Emma Katrine Hansen, Doctor, Phone: +45 21 15 84 08, Email: emma.katrine.hansen.02@regionh.dk
Additional Information
Starting date: June 2015
Last updated: June 26, 2015
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