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

Migraine Clinical Trial

Official title:

Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03481400
• Other study ID #: H-16014580
• Status: Recruiting
• Phase: N/A
• First received: March 13, 2018
• Last updated: March 27, 2018
• Start date: July 2016
• Est. completion date: September 2019

Study information

• Verified date: March 2018
• Source: Danish Headache Center
• Contact: Casper E Christensen, MD
• Phone: 38632027
• Email: casper.emil.christensen.03[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Calcitonin Gene-Related Peptide
Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)

Other:
• Placebo
Isotonic saline

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Rigshospitalet Glostrup	Copenhagen	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	Incidence of migraine	Incidence of migraine after CGRP infusion	From 0 to 12 hours after CGRP infusion
Primary	Area under the curve of headache intensity	Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion	From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion
Secondary	Heart rate	Heart rate (beats per minute)	From 0 to 90 minutes after infusion
Secondary	Blood pressure	Blood pressure (millimeter of mercury)	From 0 to 90 minutes after infusion