The Effect of Sumatriptan and Placebo on CGRP Induced Headache

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Drug: Calcitonin Gene Related Peptide; Drug: Sumatriptan 50 mg; Drug: Placebo Oral Tablet

• Registration Number: NCT03542357
• Lead Sponsor: Danish Headache Center

Brief Summary

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.

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 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.

Study Timeline

• Study First Submitted: 2017-10-20
• Study Start: 2018-02-15
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sumatriptan	Sumatriptan 50 mg	headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
Placebo	Placebo Oral Tablet	headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
Sumatriptan	Calcitonin Gene Related Peptide	headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
Placebo	Calcitonin Gene Related Peptide	headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment

Primary Outcome Measures

Name	Time	Method
AUC after infusion	1 year	The investigators will assess the outcome measures 1 year after the beginning of the study

Trial Locations

Locations (1)

Rigshospitalet Glostrup; 🇩🇰 Glostrup, Denmark