CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment

NCT ID: NCT03481400

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-09-30

Brief Summary

The investigators aim to investigate the incidence of migraine attacks after calcitonin gene-related peptide (CGRP) infusion in patients who have tried anti-CGRP monoclonal antibody treatment for the prevention of migraine.

Detailed Description

Calcitonin gene-related peptide (CGRP) plays a role in migraine pathophysiology. Infusions of CGRP can trigger migraine-like attacks in migraine patients and antibodies against CGRP or the CGRP receptor significantly reduces the number of migraine days per month when administered regularly. Some patients however, do not experience migraine attack after CGRP infusion, and some do not experience migraine reduction with antibodies. The underlying mechanisms of these effects are largely unknown.

The purpose of this study is to examine CGRP-induced migraine in patients who have evaluated the efficacy of anti-CGRP monoclonal antibody treatment for migraine using a purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to examine migraine susceptibility to CGRP in these patients.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Calcitonin gene-related peptide

Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)

Group Type: EXPERIMENTAL

Calcitonin Gene-Related Peptide

Intervention Type: DRUG

Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)

Placebo

Infusion with placebo (isotonic saline)

Group Type: EXPERIMENTAL

Placebo

Intervention Type: OTHER

Isotonic saline

Interventions

Calcitonin Gene-Related Peptide

Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)

Intervention Type: DRUG

Placebo

Isotonic saline

Intervention Type: OTHER

Other Intervention Names

CGRP

Eligibility Criteria

Inclusion Criteria

• Diagnosis of migraine according to the international classification of headache disorders version 3-beta
• Subject has tried anti-CGRP antibodies for migraine
• Women of childbearing potential are on safe contraception

Exclusion Criteria

• Women of childbearing potential who do not use contraception. Includes non-hysterectomized women who have not been menopausal for at least two years. Safe contraception includes condoms, intrauterine devices, p-pills, surgical sterilization or gestagen injections.
• Daily drug intake apart from contraceptives and preventive medication for migraine.
• Ingestion of any drug 4 half-lifes before study start apart from contraceptives.
• Pregnant or breast-feeding women
• Migraine on the study day or less than 48 hours before CGRP infusion.
• A history of cardiovascular and/or cerebrovascular disease
• Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 100 mmHg on study day.
• Systolic blood pressure <90 mmHg and/or diastolic blood pressure < 50 mmHg on study day.
• A history of mental illness
• A history of any illness or condition that is deemed relevant for participation by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Casper Emil Christensen

MD, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Messoud Ashina, prof.

Role: STUDY_DIRECTOR

Danish Headache Center

Locations

Danish Headache Center, Rigshospitalet Glostrup

Copenhagen, Glostrup, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Casper E Christensen, MD

Role: CONTACT

casper.emil.christensen.03@regionh.dk

38632027

Samaira Younis, MD

Role: CONTACT

samaira.younis.01@regionh.dk

38632176

Facility Contacts

Casper E Christensen, MD

Role: primary

casper.emil.christensen.03@regionh.dk

38632027

Samaira Younis, MD

Role: backup

samaira.younis.01@regionh.dk

38633863

References

Christensen CE, Younis S, Deen M, Khan S, Ghanizada H, Ashina M. Migraine induction with calcitonin gene-related peptide in patients from erenumab trials. J Headache Pain. 2018 Nov 8;19(1):105. doi: 10.1186/s10194-018-0927-2.

Reference Type: DERIVED

PMID: 30409109 (View on PubMed)

Other Identifiers

H-16014580

Identifier Type: -

Identifier Source: org_study_id