The Effect of Sumatriptan and Placebo on CGRP Induced Headache

Danish Headache Center

Status: Completed

Conditions: Migraine

Treatments: Drug: Calcitonin Gene Related Peptide; Drug: Placebo Oral Tablet; Drug: Sumatriptan 50 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03542357

H-16000065

Details and patient eligibility

About

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Full 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 Calcitonine Gene Related Peptide (CGRP) 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: CGRP 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy:

Healthy subjects of both sexes Age 18-60 years Weight 45-95 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 18-60 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) Triptan non-responders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Sumatriptan

Active Comparator group

Description:

headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment

Treatment:

Drug: Sumatriptan 50 mg

Drug: Calcitonin Gene Related Peptide

Placebo

Placebo Comparator group

Description:

headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment

Treatment:

Drug: Placebo Oral Tablet

Drug: Calcitonin Gene Related Peptide