Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers

Sponsor

Danish Headache Center (Other)

Overall Status

Completed

CT.gov ID

NCT03156920

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Placebo Drug: Sumatriptan	N/A

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

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model

Actual Study Start Date :

May 23, 2017

Actual Primary Completion Date :

Oct 18, 2017

Actual Study Completion Date :

Oct 18, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Sumatriptan

Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of sumatriptan 50 mg

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

Placebo Comparator: Placebo

Headache is induced with Cilostazol. This headache is pre-treated double-blinded with 2 tablets of placebo

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

Outcome Measures

Primary Outcome Measures

Difference in median headache score 2 hours after cilostazol [2 hours]
The investigators will assess the outcome measures 1 year after the beginning of the study
Area under the headache score curve [12 hours]
The investigators will assess the outcome measures 1 year after the beginning of the study

Secondary Outcome Measures

Difference in peak headache score [12 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Katrine Falkenberg	Copenhagen	Glostrup	Denmark	2600

Sponsors and Collaborators

Danish Headache Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katrine Falkenberg, Medical doctor, PhD student, principal investigator, Danish Headache Center

ClinicalTrials.gov Identifier:

NCT03156920

Other Study ID Numbers:

H-15011960

First Posted:

May 17, 2017

Last Update Posted:

Oct 19, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Migraine Disorders

Headache

Sumatriptan

Study Results

No Results Posted as of Oct 19, 2017