Back to resultsCGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment
Primary Purpose
Migraine
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcitonin Gene-Related Peptide
Placebo
Sponsored by
About this trial
This is an interventional other trial for Migraine focused on measuring Calcitonin gene-related peptide
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.
Sites / Locations
- Danish Headache Center, Rigshospitalet GlostrupRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Calcitonin gene-related peptide
Placebo
Arm Description
Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)
Infusion with placebo (isotonic saline)
Outcomes
Primary Outcome Measures
Incidence of migraine
Incidence of migraine after CGRP infusion
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
Secondary Outcome Measures
Heart rate
Heart rate (beats per minute)
Blood pressure
Blood pressure (millimeter of mercury)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03481400
Brief Title
CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment
Official Title
Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Calcitonin gene-related peptide
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Placebo-controlled, crossover design.
Masking
ParticipantInvestigator
Masking Description
Double-blind study.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Calcitonin gene-related peptide
Arm Type
Experimental
Arm Description
Calcitonin gene-related peptide infusion (1.5 micrograms/min for 20 mins)
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Infusion with placebo (isotonic saline)
Intervention Type
Drug
Intervention Name(s)
Calcitonin Gene-Related Peptide
Other Intervention Name(s)
CGRP
Intervention Description
Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Isotonic saline
Primary Outcome Measure Information:
Title
Incidence of migraine
Description
Incidence of migraine after CGRP infusion
Time Frame
From 0 to 12 hours after CGRP infusion
Title
Area under the curve of headache intensity
Description
Area under the curve of headache intensity from 0-90 min and 90 min-12 hours post infusion
Time Frame
From 0 to 90 minutes after infusion and from 90 minutes to 12 hours after infusion
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate (beats per minute)
Time Frame
From 0 to 90 minutes after infusion
Title
Blood pressure
Description
Blood pressure (millimeter of mercury)
Time Frame
From 0 to 90 minutes after infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casper E Christensen, MD
Phone
38632027
Email
casper.emil.christensen.03@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Samaira Younis, MD
Phone
38632176
Email
samaira.younis.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, prof.
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center, Rigshospitalet Glostrup
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casper E Christensen, MD
Phone
38632027
Email
casper.emil.christensen.03@regionh.dk
First Name & Middle Initial & Last Name & Degree
Samaira Younis, MD
Phone
38633863
Email
samaira.younis.01@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30409109
Citation
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.
Results Reference
derived
Learn more about this trial
CGRP-induced Migraine Attacks in Patients Who Have Tried Anti-CGRP Monoclonal Antibody Treatment
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