MigrainePhase 3OASIS(EM)NCT03836040
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
A Phase 3 study testing Erenumab Dose 1, Erenumab Dose 2 and Erenumab Dose 3 in people with Migraine, run by Amgen at 11 sites in 4 countries.
Trial summary
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab Dose 1, Erenumab Dose 2 and Erenumab Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 457 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 19 Jul 2019to 17 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.
- Participant's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or participant self-report or parents' or legal representative's report.
- The following ICHD-3 specifications for pediatric migraine (participants aged less than 18 years), should be considered for the diagnosis of migraine:
- Attacks may last 2 to 72 hours.
- Migraine headache is more often bilateral than in adults; unilateral pain usually emerges in late adolescence or early adult life.
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- Migraine headache is usually frontotemporal. Occipital headache in children is rare and calls for diagnostic caution.
- A subset of otherwise typical participants have facial location of pain, which is called 'facial migraine' in the literature; there is no evidence that these participants form a separate subgroup of migraine participants.
- In young children, photophobia and phonophobia may be inferred from their behavior.
- History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the participant as migraine days in each of the 3 months prior to screening (refer to Section 5.6 for definition of migraine day).
- Criteria to be assessed prospectively during the 4-week baseline phase and confirmed before randomizing the participant into the DBTP:
- Migraine frequency: greater than or equal 4 and less than 15 migraine days based on the eDiary data during the last 28 days of the baseline phase if greater than 28 days in duration
- Headache frequency: less than 15 headache days based on the eDiary data during the last 28 days of the baseline phase if greater than 28 days in duration.
- Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if greater than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase).
Who cannot join
- History of cluster headache or hemiplegic migraine headache.
- No therapeutic response with greater than 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- Category 1: beta blockers (eg, propranolol, atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, timolol)
- Category 2: tricyclic antidepressants (eg, amitriptyline, nortriptyline, protriptyline)
- Category 3: topiramate
- Category 4: divalproex sodium, sodium valproate
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- Category 5: serotonin-norepinephrine reuptake inhibitors (eg, venlafaxine, desvenlafaxine, duloxetine, milnacipran)
- Category 6: cyproheptadine
- Category 7: flunarizine, cinnarizine
- Category 8: botulinum toxin
- Category 9: lisinopril/candesartan
- Category 10: medications targeting the CGRP pathway.
- No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
- The following scenarios do not constitute lack of therapeutic response:
- Lack of sustained response to a medication.
- Partial, suboptimal response to a medication.
- Failure to tolerate a therapeutic dose.
- Evidence of drug or alcohol abuse or dependence within 12 months before screening, based on medical records, participant self-report, or positive urine drug test performed during screening (with the exception of prescribed medications such as opioids or barbiturates).
- Human immunodeficiency virus (HIV) infection by history.
- History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary.
- History of major psychiatric disorder (such as schizophrenia, schizoaffective disorder, bipolar disorder, obsessive-compulsive disorder, or pervasive developmental disorder), or current evidence of major depressive disorder based on a patient health questionnaire-9 modified for adolescents (PHQ-A) score greater than or equal to 10 at screening. Participants with anxiety disorder and/or mild major depressive disorder (with PHQ-A score ≤ 9) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Participant must have been on a stable dose within the 3 months before the start of the baseline phase.
- Use of prohibited medication within 1 month before the start of the baseline phase and/or during the baseline phase.
- Use of prohibited devices (such as stimulation devices) or procedures (such as acupuncture, biofeedback, relaxation techniques, or psychotherapy) with the goal of preventing migraines, within 3 months before the start of the baseline phase and/or during the baseline phase.
- Participants receiving Cognitive Behavioral Therapy (CBT) are excluded unless they are on a stable, maintenance phase of a CBT program for migraine for at least 3 months before the start of the baseline phase. Participants undergoing CBT are considered on a stable, maintenance phase if they have undergone greater than or equal 6 weekly or biweekly sessions of CBT administered by adequately trained psychologists and who, for at least 3 months before the start of the baseline phase, only follow "booster" CBT sessions at a monthly, bimonthly or quarterly frequency. Note: Participants who have discontinued CBT within 3 months prior to the start of the baseline phase are eligible for the study provided that there is evidence of CBT failure/lack of efficacy prior to initial screening (per medical records or investigator's assessment).
- Received botulinum toxin in the head and/or neck region within 4 months before the start of the baseline phase or during the baseline phase.
- Received medication targeting the CGRP pathway within 4 months before the start of the baseline phase or during the baseline phase.
- Taken the following for any indication in any month during the 2 months before the start of the baseline phase, or during the baseline phase:
- Ergotamines or triptans on greater than or equal 10 days per month.
- Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on greater than or equal 15 days per month.
- Opioid or butalbital-containing analgesics on greater than or equal 4 days per month.
- Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- Participant has clinically significant vital signs, laboratory results, or ECG abnormality during screening that, in the opinion of the investigator, could pose a risk to participant safety or interfere with the study evaluation.
- Hepatic disease by history or total bilirubin (TBL) greater than or equal 2.0 x upper limit of normal (ULN) or alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal 3.0 x ULN, as assessed by the central laboratory at initial screening.
- Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during the study and for an additional 16 weeks after the last dose of investigational product. (Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine and serum pregnancy test.)
- Female participants of childbearing potential unwilling to use an acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant's legal representative and investigator's knowledge.
- 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 participant safety or interfere with the study evaluation, procedures or completion.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Poland5 sites
AthleticoMed
Bydgoszcz, 85-752
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-355
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 60-848
Dr Sekowska Leczenie Bolu
Warsaw, 01-018
Migre Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, 52-210
Colombia4 sites
Solano y Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia Uniendo
Bogota, Cundinamarca, 110221
Fundacion Hospital Infantil Universitario De San Jose
Bogota, Cundinamarca, 111221
Servicios de Salud Ips Suramericana Sas - Ips Sura Industriales
Medellín, Antioquia, 50021
Institucion Prestadora de Servicios de Salud Sociedad Médica Rionegro SA Somer SA
Rionegro, Antioquia, 054040
United States1 site
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Read the detailed description
This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine.
The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the DBTP (24 weeks for Group 1 participants; 12-weeks for Group 2 participants) in which participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's body weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug).
The study intends to enroll 436 participants (376 adolescents and up to 60 children).
- Conditions
- Migraine
- Being tested
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3, Placebo
- Keywords
- Migraine, Headache, Prevention, Pediatric, Episodic Migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab Dose 1Drug
Also called AMG334, Aimovig®
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 2Drug
Also called AMG 334, Aimovig®
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Erenumab Dose 3Drug
Also called AMG 334, Aimovig®
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
PlaceboOther
Placebo matching dose for erenumab dose 1, 2 and 3.
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Experimental | Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2. Receives: Drug: Erenumab Dose 1; Drug: Erenumab Dose 2 |
| Dose level 2 | Experimental | Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2. Receives: Drug: Erenumab Dose 2; Drug: Erenumab Dose 3 |
| Placebo | Placebo comparator | Participants will be randomized to a placebo comparator. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MMDs
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
Measured: Baseline through week 12 of the double blind treatment phase
Secondary outcomes (13)
Change in monthly headache days from baseline
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP
Measured: Baseline through week 12 of the double blind treatment phase
Proportion of participants with at least 50% reduction in MMDs from baseline
To evaluate the effect of erenumab compared with placebo on the proportion of participants with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP
Measured: Baseline through week 12 of the double blind treatment phase
Change in MMDs from baseline to the average of the first 3 months
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the DBTP
Measured: Baseline through week 12 of the double blind treatment phase
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP. This will be measured in a daily electronic diary (eDiary) with a visual analogue scale.
Measured: Baseline through week 12 of the double blind treatment phase
Change from baseline in migraine-related disability and productivity
To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to week 9 through week 12 (month 3) of the DBTP.
Measured: Baseline through week 12 of the double blind treatment phase
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs.
Measured: Up to week 80
Change from baseline in C Terminal Telopeptide of Type 1 Collagen (CTX) Markers at assessment time points
Measured: Up to week 64
Change from baseline in Procollagen Type 1 N Propeptide (P1NP) Markers at assessment time points
Measured: Up to week 64
Number of Participants Expressing Anti-erenumab Antibodies
Measured: Up to week 80
Change in Growth and Development Rate as Assessed by Physical Measurements Based on Age-adjusted Z-scores for Height and Weight
Measured: Up to week 80
Number of Participants Experiencing Treatment-emergent Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to week 64
Group 1 Only: Number of Participants Experiencing Injection Site Pain as Assessed by Face Pain Scale-revised (FPS-R)
Measured: Day 1 and week 20
Group 2 Only: Number of Participants Experiencing Injection Site Pain as Assessed by FPS-R
Measured: Day 1 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start19 Jul 2019
- Primary completion19 Nov 2025
- Study completion17 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836040
- Sponsor's protocol ID
- 20150125
- Other IDs
- 2023-504930-23, 2023
- Acronym
- OASIS(EM)
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2019
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])
- ClinicalTrials.gov ID
- NCT03836040
- Acronym / sponsor ID
- OASIS(EM) / 20150125
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Prevention, Pediatric, Episodic Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 457 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 11 Feb 2019 (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.
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Detailed description
This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with episodic migraine.
The trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the DBTP (24 weeks for Group 1 participants; 12-weeks for Group 2 participants) in which participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's body weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug).
The study intends to enroll 436 participants (376 adolescents and up to 60 children).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Experimental | Drug: Erenumab Dose 1, Drug: Erenumab Dose 2Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2. |
| Dose level 2 | Experimental | Drug: Erenumab Dose 2, Drug: Erenumab Dose 3Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomized to a placebo comparator. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Criteria to be assessed prospectively during the 4-week baseline phase and confirmed before randomizing the participant into the DBTP:
Key exclusion criteria (38 listed)
- No therapeutic response with greater than 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. These medication categories are:
- No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.
- The following scenarios do not constitute lack of therapeutic response:
- Taken the following for any indication in any month during the 2 months before the start of the baseline phase, or during the baseline phase:
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 |
|---|---|---|
| Erenumab Dose 1Also: AMG334, Aimovig®Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose. | Drug | Dose level 1 |
| Erenumab Dose 2Also: AMG 334, Aimovig®Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose. | Drug | Dose level 1, Dose level 2 |
| Erenumab Dose 3Also: AMG 334, Aimovig®Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose. | Drug | Dose level 2 |
| PlaceboPlacebo matching dose for erenumab dose 1, 2 and 3. | Other | Placebo |
Primary outcome
Change from baseline in MMDs
Time frame: Baseline through week 12 of the double blind treatment phase
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
13 secondary outcomes
Change in monthly headache days from baseline
Time frame: Baseline through week 12 of the double blind treatment phase
Proportion of participants with at least 50% reduction in MMDs from baseline
Time frame: Baseline through week 12 of the double blind treatment phase
Change in MMDs from baseline to the average of the first 3 months
Time frame: Baseline through week 12 of the double blind treatment phase
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Time frame: Baseline through week 12 of the double blind treatment phase
Change from baseline in migraine-related disability and productivity
Time frame: Baseline through week 12 of the double blind treatment phase
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to week 80
Change from baseline in C Terminal Telopeptide of Type 1 Collagen (CTX) Markers at assessment time points
Time frame: Up to week 64
Change from baseline in Procollagen Type 1 N Propeptide (P1NP) Markers at assessment time points
Time frame: Up to week 64
Number of Participants Expressing Anti-erenumab Antibodies
Time frame: Up to week 80
Change in Growth and Development Rate as Assessed by Physical Measurements Based on Age-adjusted Z-scores for Height and Weight
Time frame: Up to week 80
Number of Participants Experiencing Treatment-emergent Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to week 64
Group 1 Only: Number of Participants Experiencing Injection Site Pain as Assessed by Face Pain Scale-revised (FPS-R)
Time frame: Day 1 and week 20
Group 2 Only: Number of Participants Experiencing Injection Site Pain as Assessed by FPS-R
Time frame: Day 1 and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erenumab Dose 1, Erenumab Dose 2 and Erenumab Dose 3 in people with Migraine, run by Amgen at 11 sites in 4 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 14 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, Colombia, United States, Belgium. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in MMDs (time frame: Baseline through week 12 of the double blind treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.