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Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Calcitonin Gene-Related Peptide
Erenumab
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Migraine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years of age upon entry into screening
  • History of migraine with or without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
  • ≥ 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening
  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase.

Exclusion Criteria:

  • > 50 years of age at migraine onset
  • History of cluster headache or hemiplegic migraine
  • Inability to differentiate migraine from other headaches
  • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
  • Previously received erenumab (Aimovig)
  • Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion
  • Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
  • Female subjects of childbearing potential with a positive pregnancy test during any study visit
  • Female subject is pregnant or breastfeeding or planning to become pregnant during the study
  • Evidence of current pregnancy or breastfeeding
  • Female subject of childbearing potential unwilling to use an acceptable method of effective contraception
  • Hypertension on the experimental day defined as systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg
  • Hypotension on the experimental day defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 50mmHg
  • Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion
  • Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge

Sites / Locations

  • Danish Headache CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Arm

Arm Description

Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes. Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)

Outcomes

Primary Outcome Measures

Headache Diary (Baseline Phase and Treatment Phase)
Headache diary with daily entries to record migraine-related data (e.g. migraine days, headache days, number of days with use of acute migraine medication, number of days with aura).

Secondary Outcome Measures

Headache Diary (Provocation Phase)
Subjects will be instructed to fill out a headache diary during the 12-hour observational period. The diary will be used to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, and phonophobia)
Semi-Structured Interview
In-person semi-structured interview to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, phonophobia, premonitory symptoms, postdromal symptoms, trigger factors, autonomic symptoms).

Full Information

First Posted
October 6, 2020
Last Updated
October 21, 2022
Sponsor
Danish Headache Center
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1. Study Identification

Unique Protocol Identification Number
NCT04592952
Brief Title
Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
Official Title
Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (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
No

5. Study Description

Brief Summary
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.
Detailed Description
This is a single-center, non-randomized, single-arm, open-label study, in which adults with episodic or chronic migraine will receive intravenous infusion with calcitonin gene-related peptide and subsequently be treated with erenumab. The study will consist of the following elements: Provocation Phase (1 experimental day with intravenous infusion of calcitonin gene-related peptide) Screening/Baseline Phase (4 weeks) Open-Label Treatment Phase (24 weeks)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm
Arm Type
Experimental
Arm Description
Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes. Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)
Intervention Type
Drug
Intervention Name(s)
Calcitonin Gene-Related Peptide
Other Intervention Name(s)
CGRP
Intervention Description
Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
Intervention Type
Drug
Intervention Name(s)
Erenumab
Other Intervention Name(s)
Aimovig
Intervention Description
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
Primary Outcome Measure Information:
Title
Headache Diary (Baseline Phase and Treatment Phase)
Description
Headache diary with daily entries to record migraine-related data (e.g. migraine days, headache days, number of days with use of acute migraine medication, number of days with aura).
Time Frame
Baseline Phase (Day -28 to Day 1) to Week 24
Secondary Outcome Measure Information:
Title
Headache Diary (Provocation Phase)
Description
Subjects will be instructed to fill out a headache diary during the 12-hour observational period. The diary will be used to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, and phonophobia)
Time Frame
Provocation Phase (12 Hours)
Title
Semi-Structured Interview
Description
In-person semi-structured interview to record migraine-related data (e.g. location, quality, intensity, aggravation by routine physical activity, use of acute migraine medication, nausea, vomiting, photophobia, phonophobia, premonitory symptoms, postdromal symptoms, trigger factors, autonomic symptoms).
Time Frame
1 Hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years of age upon entry into screening History of migraine with or without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria ≥ 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening Subject has provided informed consent prior to initiation of any study-specific activities/procedures. Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase. Exclusion Criteria: > 50 years of age at migraine onset History of cluster headache or hemiplegic migraine Inability to differentiate migraine from other headaches The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion Previously received erenumab (Aimovig) Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. Female subjects of childbearing potential with a positive pregnancy test during any study visit Female subject is pregnant or breastfeeding or planning to become pregnant during the study Evidence of current pregnancy or breastfeeding Female subject of childbearing potential unwilling to use an acceptable method of effective contraception Hypertension on the experimental day defined as systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg Hypotension on the experimental day defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 50mmHg Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Messoud Ashina, MD
Phone
+4538633385
Email
ashina@dadlnet.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Ashina, MD
Phone
+4528102495
Email
haakan.ashina@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hakan Ashina, MD
Email
haakan.ashina@regionh.dk
First Name & Middle Initial & Last Name & Degree
Messoud Ashina, MD
Email
ashina@dadlnet.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab

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