The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache

Sponsor

Danish Headache Center (Other)

Overall Status

Completed

CT.gov ID

NCT02485340

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.5

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 and in patients with migraine without aura with a long lasting Nitrogen Oxide (NO) donor. If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: 5-ISMN (isosorbide-5-mononitrate) Drug: Sumatriptan Drug: Placebo	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 Isosorbide-5-mononitrate (5-ISMN), a long lasting NO-donor, 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: 5-ISMN 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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Sumatriptan and Placebo on Isosorbide-5-mononitrate Induced Headache. Development of a Pragmatic Migraine Model

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sumatriptan headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg	Drug: 5-ISMN (isosorbide-5-mononitrate) 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan Other Names: Imdur Drug: Sumatriptan 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan Other Names: Imigran
Placebo Comparator: Placebo headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)	Drug: 5-ISMN (isosorbide-5-mononitrate) 5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan Other Names: Imdur Drug: Placebo 5-ISMN 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 5-ISMN. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg

Drug: 5-ISMN (isosorbide-5-mononitrate)

5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Other Names:

Imdur

Drug: Sumatriptan

5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Other Names:

Imigran

Placebo Comparator: Placebo

headache is induced with 5-ISMN. This headache is treated double-blinded with 1 tablet of placebo (the tablet is similar to the active tablet)

Drug: 5-ISMN (isosorbide-5-mononitrate)

5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Other Names:

Imdur

Drug: Placebo

5-ISMN 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

Median headache score 0 hours after sumatriptan/placebo [0 hours]
Median headache score 2 hours after sumatriptan/placebo [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 International headache society (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, and intake of daily medication (except oral contraceptives).