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Completed

NCT Number: NCT03542357

The Effect of Sumatriptan and Placebo on CGRP Induced Headache

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcitonin Gene Related Peptide

Drug

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

Other names: CGRP

Sumatriptan 50 mg

Drug

CGRP 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 oral tablet

Drug

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

Primary outcomes

  1. AUC after infusion

    Time frame: 1 year

    The investigators will assess the outcome measures 1 year after the beginning of the study

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 31, 2018
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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