CompletedNCT03971071Updated Sep 19, 2025Results posted

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

A Phase 4 interventional study of Erenumab 70 mg and Erenumab 140 mg in Migraine Headache, sponsored by Amgen. Completed at 94 sites in 12 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Amgen · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 620
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study summary

Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).

Read the detailed description

Study 20170703 is a phase 4, randomized, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the safety and efficacy of erenumab against placebo in a CM population with MOH and prior history of treatment failure. Participants will be enrolled based on fulfilment of the International Classification of Headache Disorders, 3rd Edition (ICHD-3) CM and MOH criteria and will not be advised to early discontinue acute medication.

Participants who successfully complete the 24-week double-blind treatment period (DBTP) of the study will be offered an opportunity to continue in an open-label treatment period (OLTP) of 28-weeks duration. Participants who received erenumab treatment during the DBTP will continue to receive the same erenumab dose during the OLTP. Participants who received placebo during the DBTP will be allocated in a 1:1 ratio to receive either erenumab 70 mg or 140 mg SC QM during the OLTP. All participants will remain blinded to their original DBTP treatment assignment.

Conditions studied

Migraine Headache

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Keywords

Chronic Migraine
Medication Overuse Headache

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 620 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Eligibility criteria will be evaluated during the up to 3-week screening period (part 1) and a 4-week baseline period (part 2). At the end of baseline period, participants who successfully met eligibility criteria will be randomized on study.

Key Inclusion Criteria Part 1: To be assessed during the 3-week screening period, prior to the baseline period. Participants are eligible to be included in the study only if all of the following criteria apply:

Participant has provided informed consent prior to initiation of any study-specific activities/procedures
Age ≥ 18 years on entry into the study
Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 classification for ≥ 12 months at screening
Documented history of CM for a minimal duration of 6 months before screening
Current diagnosis of MOH
History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability

Key Exclusion Criteria Part 1

Participants are excluded from the study if any of the following criteria apply:

Disease Related

Age > 50 years at migraine onset or > 65 years at CM onset
History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia
Current concomitant diagnosis of a secondary type of headache other than MOH
No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 preventive treatment categories
Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months prior to start of baseline
Received botulinum toxin in the head and/or neck region within 4 months prior to screening
Documented history of treatment with an anti-calcitonin gene-related peptide product preventive treatment
Anticipated to require any excluded medication/device or procedure during the study

Other Medical Conditions

History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
Evidence of "recreational use" of illicit drugs within 12 months prior to screening, based on medical records, self-report, or a positive drug test performed during screening.

Key Inclusion Criteria Part 2. To be assessed at the end of the baseline period and prior to enrollment into DBTP. Based on information collected through the electronic diary (eDiary) during the baseline period, the following requirements must be met:

-≥ 14 headache days during the 28-day baseline period out of which ≥ 8 headache days meet criteria as migraine days

Observation of acute migraine medication overuse during the baseline period. Medication overuse at baseline is defined as:
≥ 10 days of combination treatment OR
≥ 10 days of short-acting opioids/opioid-containing medication OR
≥ 10 days of triptans, ergots, OR
≥ 15 days of nonsteroidal anti-inflammatory drugs or simple analgesics intake
At least 2 acute headache medication days per week for each week with at least 5 diary days
Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline period)

Key Exclusion Criteria Part 2

Study Procedures

Changed or planning to change the dose of an allowed concomitant medication that may have migraine preventive effect during baseline period or post-randomization
Unstable or clinically significant medical condition 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

Contraception, pregnancy or breastfeeding

Unwillingness to maintain acceptable contraception method, when applicable
Evidence of pregnancy or breastfeeding per participant self-report, medical records or positivity on baseline pregnancy screening tests, through end of study

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 620 participants (actual)

Study arms

Placebo comparator
Placebo
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Drug: Placebo
Active comparator
Erenumab 70 mg
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Drug: Erenumab 70 mg
Active comparator
Erenumab 140 mg
After participants complete the baseline period and are found eligible, they will be enrolled and randomized in a 1:1:1 ratio to either erenumab (70 mg or 140 mg) or placebo.
Drug: Erenumab 140 mg

Interventions

DrugErenumab 70 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Also known as: Aimovig
DrugErenumab 140 mg
Erenumab once every 4 weeks. Subcutaneous injection.
Also known as: Aimovig
DrugPlacebo
Placebo once every 4 weeks. Subcutaneous injection.

What researchers measure

Primary outcomes

Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) \< 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days \< 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication.
Time frame: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP

Secondary outcomes

Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
An AHMD was defined as a calendar day in which the participant takes at least 1 acute headache medication. Acute headache medications included triptan-based, ergotamine-based and ditan-based migraine medications, non-opioid and opioid-containing acute headache medications, non-opioid butalbital and opioid-containing butalbital containing medications.
Time frame: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Number of Participants With Sustained MOH Remission at Month 6
Sustained MOH remission was defined as the absence of MOH at month 3 (week 12) and month 6 (week 24) of the DBTP. Absence of MOH was achieved when mean monthly AHMD \< 10 days or mean monthly headache days \< 14 days over the 3-month period (weeks 12 to 24).
Time frame: Month 3 (week 12) to month 6 (week 24) of the DBTP
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The physical impairment domain includes 5 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.
Time frame: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The impact on everyday activities domain includes 7 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.
Time frame: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as any adverse event (AE) that started on or after first dose of IP, and up to the end of the study (52 weeks). Any clinically significant changes in vital signs were included as TEAEs.
Time frame: Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)

Results

Posted Oct 13, 2023

Participant flow

Participants were enrolled at 67 study centers in North America, Europe, and Australia, and participated from 07 October 2019 to 13 June 2023.

Double-blind Treatment Period (DBTP)

Participant flow — Double-blind Treatment Period (DBTP)
Milestone	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)
Started	206	207	207
Opioid-treated cohort	12	12	12
Nonopioid-treated cohort	194	195	195
Completed	197	193	201
Not completed	9	14	6
Withdrew: Sponsor decision	0	1	0
Withdrew: Withdrawal by subject	7	11	6
Withdrew: Other	2	2	0

Open-label Treatment Period

Participant flow — Open-label Treatment Period
Milestone	Erenumab 70 mg (OLTP)	Erenumab 140 mg (OLTP)
Started	291	296
Completed	281	281
Not completed	10	15
Withdrew: Sponsor decision	0	1
Withdrew: Withdrawal by subject	10	13
Withdrew: Lost to follow-up	0	1

Outcome measures

PrimaryNumber of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6

Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) \< 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days \< 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication.

Time frame:: Months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Reported as:: Count of participants · Participants

Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6
Participants	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)
Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6	102	117	134

Statistical analysis

Placebo (DBTP) vs Erenumab 70 mg (DBTP) · Cochran-Mantel-Haenszel · p = 0.13 · Common odds ratio: 1.37 · 95% CI 0.92 to 2.05Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).
Placebo (DBTP) vs Erenumab 140 mg (DBTP) · Cochran-Mantel-Haenszel · p = <0.001 · Common odds ratio: 2.01 · 95% CI 1.33 to 3.05Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).

SecondaryChange From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6

An AHMD was defined as a calendar day in which the participant takes at least 1 acute headache medication. Acute headache medications included triptan-based, ergotamine-based and ditan-based migraine medications, non-opioid and opioid-containing acute headache medications, non-opioid butalbital and opioid-containing butalbital containing medications.

Time frame:: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Reported as:: Least squares mean · days per month

Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6
days per month	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)
Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6	-6.61 ± 0.41	-7.83 ± 0.41	-9.35 ± 0.41

Statistical analysis

Placebo (DBTP) vs Erenumab 70 mg (DBTP) · Linear Mixed Model · p = 0.033 (Nominal p-value is presented without multiplicity adjustment.) · Least squares mean difference: -1.23 · 95% CI -2.35 to -0.10Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.
Placebo (DBTP) vs Erenumab 140 mg (DBTP) · Linear Mixed Model · p = <0.001 (Nominal p-value is presented without multiplicity adjustment.) · Least squares mean difference: -2.74 · 95% CI -3.87 to -1.62Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.

SecondaryNumber of Participants With Sustained MOH Remission at Month 6

Sustained MOH remission was defined as the absence of MOH at month 3 (week 12) and month 6 (week 24) of the DBTP. Absence of MOH was achieved when mean monthly AHMD \< 10 days or mean monthly headache days \< 14 days over the 3-month period (weeks 12 to 24).

Time frame:: Month 3 (week 12) to month 6 (week 24) of the DBTP
Reported as:: Count of participants · Participants

Number of Participants With Sustained MOH Remission at Month 6
Participants	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)
Number of Participants With Sustained MOH Remission at Month 6	73	96	119

Statistical analysis

Placebo (DBTP) vs Erenumab 70 mg (DBTP) · Cochran-Mantel-Haenszel · p = 0.019 · Common odds ratio: 1.62 · 95% CI 1.08 to 2.43Erenumab 70 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).
Placebo (DBTP) vs Erenumab 140 mg (DBTP) · Cochran-Mantel-Haenszel · p = <0.001 · Common odds ratio: 2.63 · 95% CI 1.75 to 3.96Erenumab 140 mg versus Placebo. Common odds ratio and p-value were obtained from a Cochran-Mantel-Haenszel test, stratified by concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No).

SecondaryChange From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)

The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The physical impairment domain includes 5 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

Time frame:: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Reported as:: Least squares mean · Scores on a scale

Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)
Scores on a scale	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)
Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID)	-8.50 ± 0.86	-11.75 ± 0.87	-10.63 ± 0.86

Statistical analysis

Placebo (DBTP) vs Erenumab 70 mg (DBTP) · Linear Mixed Model · p = 0.007 (Nominal p-value is presented without multiplicity adjustment.) · Least squares mean difference: -3.25 · 95% CI -5.62 to -0.88Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.
Placebo (DBTP) vs Erenumab 140 mg (DBTP) · Linear Mixed Model · p = 0.075 (Nominal p-value is presented without multiplicity adjustment.) · Least squares mean difference: -2.13 · 95% CI -4.48 to 0.22Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.

SecondaryChange From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID

The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The impact on everyday activities domain includes 7 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden.

Time frame:: Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP
Reported as:: Least squares mean · Scores on a scale

Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID
Scores on a scale	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)
Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID	-10.91 ± 0.84	-13.52 ± 0.85	-13.29 ± 0.84

Statistical analysis

Placebo (DBTP) vs Erenumab 70 mg (DBTP) · Linear Mixed Model · p = 0.028 (Nominal p-value is presented without multiplicity adjustment.) · Least squares mean difference: -2.61 · 95% CI -4.92 to -0.29Erenumab 70 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.
Placebo (DBTP) vs Erenumab 140 mg (DBTP) · Linear Mixed Model · p = 0.043 (Nominal p-value is presented without multiplicity adjustment.) · Least squares mean difference: -2.37 · 95% CI -4.67 to -0.07Erenumab 140 mg versus Placebo. Covariates: treatment, visit, treatment-by-visit, concomitant oral migraine preventive treatment initiated before screening and taken during baseline (Yes or No), and baseline value.

SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

TEAEs were defined as any adverse event (AE) that started on or after first dose of IP, and up to the end of the study (52 weeks). Any clinically significant changes in vital signs were included as TEAEs.

Time frame:: Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP)
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Erenumab 70 mg (OLTP)	Erenumab 140 mg (OLTP)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	130	139	142	178	182

Adverse events

Collected over Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo (DBTP)	0/206 (0%)	8/206 (3.9%)	29/206 (14.1%)
Erenumab 70 mg (DBTP)	0/207 (0%)	3/206 (1.5%)	67/206 (32.5%)
Erenumab 140 mg (DBTP)	0/207 (0%)	3/206 (1.5%)	72/206 (35%)
Erenumab 70 mg (OLTP)	0/291 (0%)	6/291 (2.1%)	65/291 (22.3%)
Erenumab 140 mg (OLTP)	0/296 (0%)	12/296 (4.1%)	75/296 (25.3%)

Most frequent serious events

Showing 10 of 31

Most frequent serious events
Event	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Erenumab 70 mg (OLTP)	Erenumab 140 mg (OLTP)
COVID-19 pneumoniaInfections and infestations	1/206	0/206	0/206	0/291	2/296
Acute myocardial infarctionCardiac disorders	1/206	0/206	0/206	0/291	0/296
CholelithiasisHepatobiliary disorders	0/206	1/206	0/206	0/291	0/296
AppendicitisInfections and infestations	1/206	0/206	0/206	1/291	0/296
Embolic pneumoniaInfections and infestations	1/206	0/206	0/206	0/291	0/296
GastroenteritisInfections and infestations	0/206	1/206	0/206	0/291	0/296
MastoiditisInfections and infestations	1/206	0/206	0/206	0/291	0/296
Periorbital cellulitisInfections and infestations	1/206	0/206	0/206	0/291	0/296
Head injuryInjury, poisoning and procedural complications	1/206	0/206	0/206	0/291	0/296
Multiple fracturesInjury, poisoning and procedural complications	1/206	0/206	0/206	0/291	0/296

Most frequent other events

Most frequent other events
Event	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Erenumab 70 mg (OLTP)	Erenumab 140 mg (OLTP)
ConstipationGastrointestinal disorders	9/206	31/206	34/206	22/291	24/296
COVID-19Infections and infestations	14/206	25/206	33/206	31/291	39/296
NasopharyngitisInfections and infestations	4/206	12/206	9/206	15/291	14/296
InsomniaPsychiatric disorders	4/206	8/206	12/206	1/291	3/296

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Total
Mean	44.3 ± 12.5	43.1 ± 11.6	43.5 ± 12.2	43.6 ± 12.1

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Total
Female	166	170	174	510
Male	40	37	33	110

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Total
Hispanic or Latino	9	10	13	32
Not Hispanic or Latino	196	197	194	587
Unknown or Not Reported	1	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo (DBTP)	Erenumab 70 mg (DBTP)	Erenumab 140 mg (DBTP)	Total
American Indian or Alaska Native	1	1	0	2
Asian	1	0	1	2
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	2	4	2	8
White	196	187	187	570
More than one race	0	0	0	0
Unknown or Not Reported	6	15	17	38

Study locations

94 sites

Core Healthcare Group
Cerritos, California 90703, United States
Axiom Research
Colton, California 92324, United States
Clinical Research Institute
Los Angeles, California 90048, United States
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia 20037, United States
University of Miami Miller School of Medicine
Miami, Florida 33136, United States
Floridian Clinical Research LLC
Miami Lakes, Florida 33016, United States
Clinical Neuroscience Solutions
Orlando, Florida 32801, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida 32504, United States
University of South Florida
Tampa, Florida 33612, United States
Saint Lukes Clinic
Meridian, Idaho 83642, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana 46804, United States
College Park Family Care Center
Overland Park, Kansas 66212, United States
Collective Medical Research
Prairie Village, Kansas 66208, United States
University of Kentucky
Lexington, Kentucky 40536, United States
DelRicht Research
New Orleans, Louisiana 70124, United States
Neurology Center of New England PC
Foxborough, Massachusetts 02035, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan 48104, United States
Clinical Research Institute Inc
Minneapolis, Minnesota 55402, United States
Citizens Memorial Healthcare
Bolivar, Missouri 65613, United States
Mercy Research
St Louis, Missouri 63141, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Dent Neurosciences Research Center
Amherst, New York 14226, United States
Onsite Clinical Solutions LLC
Charlotte, North Carolina 28277, United States
Clinical Trial Investigator Clinical Research Center
Cincinnati, Ohio 45212, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Allegheny Health Network Cancer Institute at Mellon Pavilion
Pittsburgh, Pennsylvania 15224, United States
Preferred Primary Care Physicians, Inc
Pittsburgh, Pennsylvania 15236, United States
Nashville Neuroscience Group
Nashville, Tennessee 37203, United States
Texas Neurology, PA
Dallas, Texas 75214, United States
Wasatch Clinical Research LLC
Salt Lake City, Utah 84107, United States
Marshall University
Huntington, West Virginia 25701, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311, United States
Holdsworth House Medical Practice
Sydney, New South Wales 2010, Australia
The Alfred Hospital
Melbourne, Victoria 3004, Australia
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Klinikum Klagenfurt am Woerthersee
Klagenfurt, 9020, Austria
Konventhospital der Barmherzigen Brueder Linz
Linz, 4021, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
Neurologie Brno sro
Brno, 616 00, Czechia
Fakultni nemocnice u svate Anny v Brne
Brno, 656 91, Czechia
Dado Medical sro
Prague, 120 00, Czechia
Thomayerova nemocnice
Prague, 140 59, Czechia
INEP
Prague, 186 00, Czechia
Mudr Stanislav Bartek sro
Přerov, 750 02, Czechia
Vestra Clinics sro
Rychnov nad Kněžnou, 516 01, Czechia
Helsingin Paansarkykeskus Aava
Helsinki, 00930, Finland
Northern Cinical Trial Coordinators
Oulu, 90590, Finland
Suomen Terveystalo
Tampere, 33100, Finland
Terveystalo Pulssi
Turku, 20100, Finland
Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer
Bron, 69677, France
Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
Lille, 59037, France
Hopital La Timone
Marseille, 13385, France
Centre Hospitalier Universitaire de Nice - Hopital de Cimiez
Nice, 06003, France
Hopital Lariboisiere
Paris, 75010, France
Groupe hospitalier Paris Saint Joseph
Paris, 75014, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Centre Hospitalier Annecy Genevois
Pringy, 74374, France
Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord
Saint-Etienne, 42055, France
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Swiss Premium Egeszsegkozpont
Budapest, 1123, Hungary
Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet
Budapest, 1145, Hungary
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204, Hungary
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz
Debrecen, 4026, Hungary
Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz
Miskolc, 3526, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar
Szeged, 6725, Hungary
IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria
Bologna, 40139, Italy
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, 88100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Fondazione Istituto Neurologico Nazionale C Mondino IRCCS
Pavia, 27100, Italy
IRCCS San Raffaele Pisana
Roma, 00163, Italy
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna
Ksawerów, 95-054, Poland
Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej
Legionowo, 05-120, Poland
Gabinet Lekarski Jacek Rozniecki
Lodz, 90-338, Poland
Clinical Research Center Spzoo Medic-R Spolka Komandytowa
Poznan, 60-848, Poland
RCMed Oddzial Sochaczew
Sochaczew, 96-500, Poland
Hospital Professor Doutor Fernando Fonseca, EPE
Amadora, 2720-276, Portugal
Hospital da Luz, SA
Lisbon, 1500-650, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Campus Neurologico Senior
Torres Vedras, 2560-280, Portugal
Hospital Universitario Virgen del Rocio
Seville, Andalusia 41013, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon 50009, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Castille and León 47010, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia 08035, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia 08907, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia 46010, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia 46026, Spain
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ, United Kingdom
Kings College London
London, SE5 9RS, United Kingdom
Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom

References and documents

Publications

Tepper SJ, Dodick DW, Lanteri-Minet M, Dolezil D, Gil-Gouveia R, Lucas C, Piasecka-Stryczynska K, Szabo G, Mikol DD, Chehrenama M, Chou DE, Yang Y, Paiva da Silva Lima G. Efficacy and Safety of Erenumab for Nonopioid Medication Overuse Headache in Chronic Migraine: A Phase 4, Randomized, Placebo-Controlled Trial. JAMA Neurol. 2024 Sep 16;81(11):1140-9. doi: 10.1001/jamaneurol.2024.3043. Online ahead of print. PubMed 39283627 ↗
Tepper SJ, Dodick DW, Lanteri-Minet M, Dolezil D, Gil-Gouveia R, Lucas C, Piasecka-Stryczynska K, Szabo G, Mikol DD, Chehrenama M, Chou DE, Liu Z, da Silva Lima GP. Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache: Final Results From a Phase 4 Randomized Placebo-Controlled Study. Eur J Neurol. 2025 Aug;32(8):e70328. doi: 10.1111/ene.70328. PubMed 40838472 ↗

Study documents

Study protocol · May 27, 2020
Statistical analysis plan · Dec 10, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03971071
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Jun 3, 2019
Start date: Oct 7, 2019
Primary completion: Dec 1, 2022
Completion: Jun 13, 2023
Results posted: Oct 13, 2023
Last update: Sep 19, 2025

Study contacts

study director · Amgen

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

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