The Effect of Sumatriptan and Placebo on CGRP Induced Headache

September 11, 2019 updated by: Katrine Falkenberg, Danish Headache Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Rigshospitalet Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sumatriptan
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of sumatriptan 50 mg as a pre-treatment
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
Other Names:
  • CGRP
Drug: 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
Other Names:
  • Imigran
Placebo Comparator: Placebo
headache is induced with CGRP. This headache is treated double-blinded with 1 tablet of placebo as a pre-treatment
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
Other Names:
  • CGRP
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC after infusion
Time Frame: 1 year
The investigators will assess the outcome measures 1 year after the beginning of the study
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16000065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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