MigrainePhase 4INTERROGATENCT04265755
Biomarker and Genetic Predictors of Erenumab Treatment Response
A Phase 4 study testing Erenumab in people with Migraine, run by Amgen at 2 sites in 2 countries.
Trial summary
To explore the relationship between clinical response to erenumab and genetic biomarkers Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,406 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Oct 2020to 18 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Age greater than or equal to 18 years upon entry into screening
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report
- Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening After baseline period
- Must have demonstrated greater than or equal to 75% compliance in eDiary usage during baseline period
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
- Disease Related
- Greater than 50 years of age at migraine onset
- History of cluster headache or hemiplegic migraine headache
- Inability to differentiate between migraine from other headaches. Other Medical Conditions
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour
Show all 20Show fewer
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Prior/Concomitant Therapy
- Previously received erenumab (Aimovig®)
- Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period
- Initiation, discontinuation, or change of dosing of migraine prophylactic medications within 2 months prior to the start of the baseline period, during the baseline period or planned during the study.
- Prior/Concurrent Clinical Study Experience
- 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.
- Other Exclusions
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test
- Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product
- Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product
- Evidence of current pregnancy or breastfeeding per subject self-report or medical records
- Subject has known sensitivity to any of the products or components to be administered during dosing
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)
To explore the relationship between clinical response to erenumab and genetic biomarkers
Read the detailed description
This is a phase 4 open-label study aiming to explore the relationship between clinical response to erenumab and genetic biomarkers.
Subjects with episodic or chronic migraine will be treated with Erenumab 70mg or 140mg for a 4-week baseline/screening period, followed by a 24-week treatment period.
Subjects will collect migraine-related parameters daily using an eDiary and blood samples will be collected for biomarker research. All analysis will be descriptive in nature.
- Conditions
- Migraine
- Being tested
- Erenumab
- Keywords
- Episodic and Chronic Migraine, Link between clinical response and biomarker, Phase 4
- Medical subject headings
- Migraine Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Erenumab packed in a SureClick® Autoinjector Pen (AI) Receives: Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS
A migraine day was defined as a calendar day (00:00 to 23:59) in which the participant reports any migraine headache or takes any triptan-based acute migraine-specific medication.
At least a 50% reduction from Baseline in MMDs was determined if: (average number of migraine days per month during the last 3 months [months 4, 5, and 6] of the 24-week Open-label Treatment Period minus number of migraine days during the 4-week Baseline Period) / number of migraine days during the 4-week Baseline Period * 100, was less than or equal to -50%.
Measured: 4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start26 Oct 2020
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265755
- Sponsor's protocol ID
- 20190006
- Other IDs
- 2019-002331-28, 2019
- Acronym
- INTERROGATE
- Status last verified
- Dec 2023
- First submitted
- 10 Feb 2020
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Thuraiaiyah J, Ashina H, Christensen RH, Al-Khazali HM, Wiggers A, Amin FM, Steiner TJ, Ashina M. Premonitory symptoms in migraine: A REFORM Study. Cephalalgia. 2024 Feb;44(2):3331024231223979. doi: 10.1177/03331024231223979.
PubMed 38299579
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE)
- ClinicalTrials.gov ID
- NCT04265755
- Acronym / sponsor ID
- INTERROGATE / 20190006
- Conditions
- Migraine
- Keywords
- Episodic and Chronic Migraine, Link between clinical response and biomarker, Phase 4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,406 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 7 Jun 2024
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 genetic biomarkers
Detailed description
This is a phase 4 open-label study aiming to explore the relationship between clinical response to erenumab and genetic biomarkers.
Subjects with episodic or chronic migraine will be treated with Erenumab 70mg or 140mg for a 4-week baseline/screening period, followed by a 24-week treatment period.
Subjects will collect migraine-related parameters daily using an eDiary and blood samples will be collected for biomarker research. All analysis will be descriptive in nature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: ErenumabErenumab packed in a SureClick® Autoinjector Pen (AI) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Age greater than or equal to 18 years upon entry into screening
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report
- Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening After baseline period
- Must have demonstrated greater than or equal to 75% compliance in eDiary usage during baseline period
Key exclusion criteria (20 listed)
- Disease Related
- Greater than 50 years of age at migraine onset
- History of cluster headache or hemiplegic migraine headache
- Inability to differentiate between migraine from other headaches. Other Medical Conditions
- The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour
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 |
|---|---|---|
| ErenumabAlso: AIMOVIGErenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI). | Drug | Single arm |
Primary outcome
Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS
Time frame: 4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment Period
A migraine day was defined as a calendar day (00:00 to 23:59) in which the participant reports any migraine headache or takes any triptan-based acute migraine-specific medication. At least a 50% reduction from Baseline in MMDs was determined if: (average number of migraine days per month during the last 3 months [months 4, 5, and 6] of the 24-week Open-label Treatment Period minus number of migraine days during the 4-week Baseline Period) / number of migraine days during the 4-week Baseline Period * 100, was less than or equal to -50%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38299579Thuraiaiyah J, Ashina H, Christensen RH, Al-Khazali HM, Wiggers A, Amin FM, Steiner TJ, Ashina M. Premonitory symptoms in migraine: A REFORM Study. Cephalalgia. 2024 Feb;44(2):3331024231223979. doi: 10.1177/03331024231223979.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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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.
MD study director
Amgen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erenumab in people with Migraine, run by Amgen at 2 sites in 2 countries.
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 20 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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Iceland. 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?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving at Least a 50% Reduction From Baseline in Mean MMDs Over Months 4, 5, and 6 in Relation to mPRS (time frame: 4-week Baseline Period and the last 3 months (Months 4, 5, and 6) of the 24-week Open-label Treatment Period). 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 NCT04265755, which also lists 1 linked publication.
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 7 Jun 2024.