The Effect of Sumatriptan and Placebo on CGRP Induced Headache

Migraine Clinical Trial

Official title:

The Effect of Sumatriptan and Placebo on CGRP Induced Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542357
• Other study ID #: H-16000065
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: September 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

Drug:
• Calcitonin Gene Related Peptide
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
• Sumatriptan 50 mg
CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
• Placebo Oral Tablet
CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan

Locations

Country	Name	City	State
Denmark	Rigshospitalet Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC after infusion	The investigators will assess the outcome measures 1 year after the beginning of the study	1 year