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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03156920
Other study ID # H-15011960
Secondary ID
Status Completed
Phase N/A
First received May 10, 2017
Last updated October 18, 2017
Start date May 23, 2017
Est. completion date October 18, 2017

Study information

Verified date October 2017
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 18, 2017
Est. primary completion date October 18, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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
Sumatriptan
Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Locations

Country Name City State
Denmark Katrine Falkenberg Copenhagen Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in median headache score 2 hours after cilostazol The investigators will assess the outcome measures 1 year after the beginning of the study 2 hours
Primary Area under the headache score curve The investigators will assess the outcome measures 1 year after the beginning of the study 12 hours
Secondary Difference in peak headache score 12 hours
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