MigrainePhase 3ARISENCT02483585
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
A Phase 3 study testing Erenumab in people with Migraine, run by Amgen at 76 sites in 8 countries.
Trial summary
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 577 participants
- Where
- 76 sitesin 8 countries
- Study dates
- 20 Jul 2015to 20 Mar 2017
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of migraines (with or without aura) for ≥ 12 months
- Migraine frequency: ≥ 4 and < 15 migraine days per month on average acrossthe 3 months prior to screening
- Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening
- Demonstrated compliance with the eDiary
Who cannot join
- Older than 50 years of age at migraine onset.
- History of cluster headache or hemiplegic migraine headache.
- Unable to differentiate migraine from other headaches
- No therapeutic response with > 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
- Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
- Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
Show all 15Show fewer
- Received botulinum toxin
- Anticipated to require any excluded medication, device, or procedure during the study.
- Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
- History of major psychiatric disorder.
- History of seizure disorder or other significant neurological conditions other than migraine.
- Human immunodeficiency virus (HIV) infection by history.
- Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
- The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
- Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
Trial locations and contacts
76 sites in 8 countries.
76 sites in 8 countries
United States40 sites
Research Site
Albuquerque, New Mexico, 87102
Research Site
Ann Arbor, Michigan, 48104
Research Site
Asheville, North Carolina, 28806
Research Site
Atlanta, Georgia, 30342
Research Site
Austin, Texas, 78759
Research Site
Baltimore, Maryland, 21208
Research Site
Birmingham, Alabama, 35216
Research Site
Boston, Massachusetts, 02131
Research Site
Chattanooga, Tennessee, 37421
Research Site
Cincinnati, Ohio, 45245
Research Site
Colorado Springs, Colorado, 80907
Research Site
Culver City, California, 90230
Research Site
Dallas, Texas, 75214
Research Site
Fairfield, Connecticut, 06824
Research Site
Gurnee, Illinois, 60031
Research Site
Hollywood, Florida, 33021
Research Site
Indianapolis, Indiana, 46256
Research Site
Jacksonville, Florida, 32216
Research Site
Kalamazoo, Michigan, 49009
Research Site
Lenexa, Kansas, 66214
Research Site
Lexington, Kentucky, 40513
Research Site
Long Beach, California, 90806
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Oklahoma City, Oklahoma, 73112
Research Site
Orlando, Florida, 32806
Research Site
Oviedo, Florida, 32765
Research Site
Palm Beach Gardens, Florida, 33410
Research Site
Philadelphia, Pennsylvania, 19114
Research Site
Phoenix, Arizona, 85018
Research Site
Princeton, New Jersey, 08540
Research Site
Sacramento, California, 95821
Research Site
Salt Lake City, Utah, 84121
Research Site
San Diego, California, 92103
Research Site
Santa Monica, California, 90404
Research Site
Seattle, Washington, 98105
Research Site
Virginia Beach, Virginia, 23454
Research Site
Walnut Creek, California, 94598
Research Site
Warwick, Rhode Island, 02886
Research Site
Williamsville, New York, 14221
Research Site
Winston-Salem, North Carolina, 27103
Spain8 sites
Research Site
Barcelona, Catalonia, 08035
Research Site
Madrid, 28040
Research Site
Santander, Cantabria, 39008
Research Site
Santiago de Compostela, Galicia, 15706
Research Site
Valencia, Valencia, 46010
Research Site
Valencia, Valencia, 46026
Research Site
Valladolid, Castille and León, 47005
Research Site
Zaragoza, Aragon, 50009
Switzerland6 sites
Research Site
Bad Zurzach, 5330
Research Site
Biel, 2502
Research Site
Geneva, 1205
Research Site
Lugano, 6903
Research Site
Sankt Gallen, 9007
Research Site
Zollikon, 8702
France5 sites
Research Site
Bordeaux, 33076
Research Site
Nice, 06003
Research Site
Paris, 75010
Research Site
Paris, 75014
Research Site
Pringy, 74374
Russia5 sites
Research Site
Moscow, 119435
Research Site
Moscow, 121467
Research Site
Novosibirsk, 630091
Research Site
Saint Petersburg, 197022
Research Site
Ufa, 450083
Denmark4 sites
Research Site
Aalborg, 9000
Research Site
Ballerup Municipality, 2750
Research Site
Glostrup Municipality, 2600
Research Site
Vejle, 7100
Greece4 sites
Research Site
Athens, 11521
Research Site
Athens, 11525
Research Site
Athens, 16675
Research Site
Thessaloniki, 54645
Portugal4 sites
Research Site
Amadora, 2720-276
Research Site
Lisbon, 1500-650
Research Site
Lisbon, 1649-035
Research Site
Torres Vedras, 2560-280
About this study
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.
Read the detailed description
Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.
- Conditions
- Migraine
- Being tested
- Erenumab, Placebo
- Keywords
- Migraine, Headache, Episodic, Prevention, Prophylaxis
- Medical subject headings
- Migraine Disorders, Headache, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
Also called AMG 334, Aimovig™
Administered once a month by subcutaneous injection
PlaceboDrug
Administered once a month by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase. Receives: Drug: Placebo |
| Erenumab | Experimental | Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase. Receives: Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Monthly Migraine Days at Week 12
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.
The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Secondary outcomes (6)
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment.
At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12
Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.
The change from baseline in monthly acute migraine-specific treatment days was calculated as the number of migraine-specific treatment days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine-specific treatment days during the 4-week baseline phase.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12
The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.
Achievement of at least a 5 point reduction from baseline in the monthly average domain score was calculated as (monthly average domain score during the last 4 weeks of the 12-week double-blind treatment phase - baseline monthly average domain score) was ≤ -5.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12
The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from "Without any difficulty" (1) to "Unable to do" (5) and frequency items ranging from "None of the time" (1) to "All of the time" (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.
Achievement of at least a 5 point reduction from baseline in the monthly average domain score was calculated as (monthly average domain score during the last 4 weeks of the 12-week double-blind treatment phase - baseline monthly average domain score) was ≤ -5.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Number of Participants With Adverse Events
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:
Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.
Measured: From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.
Number of Participants Who Developed Antibodies to Erenumab
Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).
Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
Transient indicates a negative result at the participant's last time point tested, for those participants with a positive binding/neutralizing result post-baseline.
Measured: Baseline (the period prior to the first dose erenumab 70 mg) and post-baseline (the period after the first dose of erenumab 70 mg until 12 weeks after last dose, up to 48 weeks total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start20 Jul 2015
- Primary completion11 Jul 2016
- Study completion20 Mar 2017
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 (8)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 577 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
- NCT02483585
- Sponsor's protocol ID
- 20120297
- Other IDs
- 2014-004463-20, 2014
- Acronym
- ARISE
- Status last verified
- Oct 2022
- First submitted
- 12 Jun 2015
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.
PubMed 29471679Cheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.
Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.
PubMed 35272533Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.
PubMed 35137394Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.
PubMed 31707815Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.
PubMed 31852816Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
PubMed 35978286Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.
PubMed 34928306
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
- ClinicalTrials.gov ID
- NCT02483585
- Acronym / sponsor ID
- ARISE / 20120297
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Episodic, Prevention, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2015 (actual)
- Primary completion
- 11 Jul 2016 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 25 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.
Detailed description
Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase. |
| Erenumab | Experimental | Drug: ErenumabParticipants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of migraines (with or without aura) for ≥ 12 months
- Migraine frequency: ≥ 4 and < 15 migraine days per month on average acrossthe 3 months prior to screening
- Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening
- Demonstrated compliance with the eDiary
Key exclusion criteria (15 listed)
- Older than 50 years of age at migraine onset.
- History of cluster headache or hemiplegic migraine headache.
- Unable to differentiate migraine from other headaches
- No therapeutic response with > 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
- Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
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: AMG 334, Aimovig™Administered once a month by subcutaneous injection | Drug | Erenumab |
| PlaceboAdministered once a month by subcutaneous injection | Drug | Placebo |
Primary outcome
Change From Baseline in Monthly Migraine Days at Week 12
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
6 secondary outcomes
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
Number of Participants With Adverse Events
Time frame: From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.
Number of Participants Who Developed Antibodies to Erenumab
Time frame: Baseline (the period prior to the first dose erenumab 70 mg) and post-baseline (the period after the first dose of erenumab 70 mg until 12 weeks after last dose, up to 48 weeks total)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29471679Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 May;38(6):1026-1037. doi: 10.1177/0333102418759786. Epub 2018 Feb 22.
- BackgroundCheng S, Picard H, Zhang F, Eisele O, Mikol DD. Efficacy and safety of erenumab for migraine prevention: an overview. Japanese Journal of Headache. 2019; 45 : 493-505.
- Background: PubMed 35272533Zhou Y, Zhang F, Starcevic Manning M, Hu Z, Hsu CP, Chen PW, Peng C, Loop B, Mytych DT, Paiva da Silva Lima G. Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions. Cephalalgia. 2022 Jul;42(8):749-760. doi: 10.1177/03331024221075621. Epub 2022 Mar 10.
- Background: PubMed 35137394Kawata AK, Ladd MK, Lipton RB, Buse DC, Bensink M, Shah S, Hareendran A, Mannix S, Mikol D. Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials. Headache. 2022 Feb;62(2):159-168. doi: 10.1111/head.14258. Epub 2022 Feb 8.
- Background: PubMed 31707815Ashina M, Kudrow D, Reuter U, Dolezil D, Silberstein S, Tepper SJ, Xue F, Picard H, Zhang F, Wang A, Zhou Y, Hong F, Klatt J, Mikol DD. Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. Cephalalgia. 2019 Dec;39(14):1798-1808. doi: 10.1177/0333102419888222. Epub 2019 Nov 10.
- Background: PubMed 31852816Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.
- Derived from this study: PubMed 35978286Lampl C, Kraus V, Lehner K, Loop B, Chehrenama M, Maczynska Z, Ritter S, Klatt J, Snellman J. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain. 2022 Aug 18;23(1):104. doi: 10.1186/s10194-022-01470-4.
- Derived from this study: PubMed 34928306Ashina M, Goadsby PJ, Dodick DW, Tepper SJ, Xue F, Zhang F, Brennan F, Paiva da Silva Lima G. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials. JAMA Neurol. 2022 Feb 1;79(2):159-168. doi: 10.1001/jamaneurol.2021.4678.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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
76 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erenumab in people with Migraine, run by Amgen at 76 sites in 8 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 4 inclusion and 15 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 12 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 76 sites in United States, Spain, Switzerland, France, Russia and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2018). 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?
Change From Baseline in Monthly Migraine Days at Week 12 (time frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase). 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 NCT02483585, which also lists 8 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 12 Oct 2022.