MigrainePhase 4NCT04592952
Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
A Phase 4 study testing Calcitonin Gene-Related Peptide and Erenumab in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial summary
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine
- What is being tested?
- Calcitonin Gene-Related Peptide and Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Oct 2020to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- > 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Copenhagen, Glostrup, 2600
Hakan Ashina, MD, haakan.ashina@regionh.dk
Messoud Ashina, MD, ashina@dadlnet.dk
About this study
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.
Read the 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)
- Conditions
- Migraine
- Being tested
- Calcitonin Gene-Related Peptide, Erenumab
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin Gene-Related PeptideDrug
Also called CGRP
Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
ErenumabDrug
Also called Aimovig
Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | 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) Receives: Drug: Calcitonin Gene-Related Peptide; Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline Phase (Day -28 to Day 1) to Week 24
Secondary outcomes (2)
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)
Measured: Provocation Phase (12 Hours)
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).
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start8 Oct 2020
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Messoud Ashina, MD, Danish Headache Center
- Investigators
- Messoud Ashina, MD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592952
- Sponsor's protocol ID
- H-20047793
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2020
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, Amin FM, Ashina M, Snellman J, Maio-Twofoot T, Schytz HW. Hypersensitivity to CGRP as a predictive biomarker of migraine prevention with erenumab. Cephalalgia. 2024 Jun;44(6):3331024241258734. doi: 10.1177/03331024241258734.
PubMed 38859744Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, Schytz HW, Amin FM, Ashina M. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: A REFORM study. Cephalalgia. 2023 Oct;43(10):3331024231206375. doi: 10.1177/03331024231206375.
PubMed 37815254Al-Khazali HM, Ashina H, Wiggers A, Rose K, Iljazi A, Christensen RH, Schytz HW, Amin FM, Ashina M. Calcitonin gene-related peptide causes migraine aura. J Headache Pain. 2023 Sep 7;24(1):124. doi: 10.1186/s10194-023-01656-4.
PubMed 37679723Karlsson WK, Ashina H, Cullum CK, Christensen RH, Al-Khazali HM, Amin FM, Ashina M; REFORM Investigators. The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics. J Headache Pain. 2023 Jun 12;24(1):70. doi: 10.1186/s10194-023-01604-2.
PubMed 37303034
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
- ClinicalTrials.gov ID
- NCT04592952
- Acronym / sponsor ID
- H-20047793
- Conditions
- Migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: Calcitonin Gene-Related Peptide, Drug: ErenumabProvocation 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- > 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitonin Gene-Related PeptideAlso: CGRPIntravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes. | Drug | Single-Arm |
| ErenumabAlso: AimovigErenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI) | Drug | Single-Arm |
Primary outcome
Headache Diary (Baseline Phase and Treatment Phase)
Time frame: Baseline Phase (Day -28 to Day 1) to Week 24
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).
2 secondary outcomes
Headache Diary (Provocation Phase)
Time frame: Provocation Phase (12 Hours)
Semi-Structured Interview
Time frame: 1 Hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Derived from this study: PubMed 38859744Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, Amin FM, Ashina M, Snellman J, Maio-Twofoot T, Schytz HW. Hypersensitivity to CGRP as a predictive biomarker of migraine prevention with erenumab. Cephalalgia. 2024 Jun;44(6):3331024241258734. doi: 10.1177/03331024241258734.
- Derived from this study: PubMed 37815254Al-Khazali HM, Ashina H, Christensen RH, Wiggers A, Rose K, Iljazi A, Schytz HW, Amin FM, Ashina M. An exploratory analysis of clinical and sociodemographic factors in CGRP-induced migraine attacks: A REFORM study. Cephalalgia. 2023 Oct;43(10):3331024231206375. doi: 10.1177/03331024231206375.
- Derived from this study: PubMed 37679723Al-Khazali HM, Ashina H, Wiggers A, Rose K, Iljazi A, Christensen RH, Schytz HW, Amin FM, Ashina M. Calcitonin gene-related peptide causes migraine aura. J Headache Pain. 2023 Sep 7;24(1):124. doi: 10.1186/s10194-023-01656-4.
- Derived from this study: PubMed 37303034Karlsson WK, Ashina H, Cullum CK, Christensen RH, Al-Khazali HM, Amin FM, Ashina M; REFORM Investigators. The Registry for Migraine (REFORM) study: methodology, demographics, and baseline clinical characteristics. J Headache Pain. 2023 Jun 12;24(1):70. doi: 10.1186/s10194-023-01604-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Messoud Ashina, MD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitonin Gene-Related Peptide and Erenumab in people with Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Messoud Ashina, MD (+4538633385, ashina@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Diary (Baseline Phase and Treatment Phase) (time frame: Baseline Phase (Day -28 to Day 1) to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592952, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.