Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
NCT ID: NCT01952574
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
483 participants
INTERVENTIONAL
2013-08-06
2019-11-12
Brief Summary
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Detailed Description
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In the DBTP participants were to be randomized in a 3:2:2:2 ratio to placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg.
During the open-label treatment phase, participants were to receive erenumab 70 mg QM from week 12 to week 264. After implementation of Protocol Amendment 3 (07 April 2016), participants remaining in the OLTP increased their dose to erenumab 140 mg QM up to week 264. The safety follow-up increased from an 8-week safety follow-up to a 12-week safety follow-up (16 weeks after the last dose of investigational product).
During the OLTP participants enrolled at sites in the United States could enroll in an optional clinical home use (CHU) substudy, per a country-specific protocol amendment dated 20 June 2016. Participants in the CHU substudy were to be randomized 1:1 into 1 of 2 treatment groups: erenumab 140 mg using a prefilled syringe or erenumab 140 mg using an autoinjector/pen. Day 1 of the CHU substudy corresponded with any OLTP study visit up through Week 256, as long as the participant had received at least 2 doses of erenumab 140 mg. During the CHU substudy, participants initially self-administered IP under site supervision on substudy day 1, and then self-administered IP at home on substudy days 29 and 57.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Erenumab
Administered by study site staff once a month (QM) as a subcutaneous injection
Placebo
Administered by study site staff once a month (QM) as a subcutaneous injection
Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Erenumab
Administered by study site staff once a month (QM) as a subcutaneous injection
Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Erenumab
Administered by study site staff once a month (QM) as a subcutaneous injection
Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase.
In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM.
Erenumab
Administered by study site staff once a month (QM) as a subcutaneous injection
CHU Substudy: Erenumab 140 mg PFS
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Erenumab PFS
Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
CHU Substudy: Erenumab 140 mg AI/Pen
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
Erenumab AI/Pen
Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
Interventions
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Erenumab
Administered by study site staff once a month (QM) as a subcutaneous injection
Placebo
Administered by study site staff once a month (QM) as a subcutaneous injection
Erenumab PFS
Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
Erenumab AI/Pen
Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
* Headache frequency: \< 15 headache days per month (with \> 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase
* Demonstrated at least 80% compliance with the eDiary during baseline phase
Exclusion Criteria
* History of cluster headache or basilar or hemiplegic migraine headache
* Unable to differentiate migraine from other headaches
* No therapeutic response with \> 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:
* Category 1: Divalproex sodium, sodium valproate
* Category 2: Topiramate
* Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
* Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
* Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
* Category 6: Flunarizine, verapamil
* Category 7: Lisinopril, candesartan
* Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)
* Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening
18 Years
60 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Long Beach, California, United States
Research Site
National City, California, United States
Research Site
Newport Beach, California, United States
Research Site
San Francisco, California, United States
Research Site
Santa Monica, California, United States
Research Site
Sherman Oaks, California, United States
Research Site
Spring Valley, California, United States
Research Site
Danbury, Connecticut, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Stamford, Connecticut, United States
Research Site
Bradenton, Florida, United States
Research Site
Melbourne, Florida, United States
Research Site
Palm Beach Gardens, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Decatur, Georgia, United States
Research Site
Wichita, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Louisville, Kentucky, United States
Research Site
Watertown, Massachusetts, United States
Research Site
Worcester, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Kalamazoo, Michigan, United States
Research Site
Southfield, Michigan, United States
Research Site
Plymouth, Minnesota, United States
Research Site
Springfield, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Rochester, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Arlington, Texas, United States
Research Site
Austin, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Falls Church, Virginia, United States
Research Site
Virginia Beach, Virginia, United States
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Aarhus C, , Denmark
Research Site
Glostrup Municipality, , Denmark
Research Site
Helsinki, , Finland
Research Site
Mikkeli, , Finland
Research Site
Oulu, , Finland
Research Site
Tampere, , Finland
Research Site
Turku, , Finland
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Essen, , Germany
Research Site
Hamburg, , Germany
Research Site
Leipzig, , Germany
Research Site
Ålesund, , Norway
Research Site
Hamar, , Norway
Research Site
Sandvika, , Norway
Research Site
Stavanger, , Norway
Research Site
Falköping, , Sweden
Research Site
Lund, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Vällingby, , Sweden
Countries
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References
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Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M, Saper J, Cady R, Chon Y, Dietrich J, Lenz R. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):382-90. doi: 10.1016/S1474-4422(16)00019-3. Epub 2016 Feb 12.
Ashina M, Dodick D, Goadsby PJ, Reuter U, Silberstein S, Zhang F, Gage JR, Cheng S, Mikol DD, Lenz RA. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology. 2017 Sep 19;89(12):1237-1243. doi: 10.1212/WNL.0000000000004391. Epub 2017 Aug 23.
Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick D, Rippon GA, Klatt J, Xue F, Chia V, Zhang F, Cheng S, Mikol DD. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.
Cheng 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.
Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F, Zhang F, Paiva da Silva Lima G, Cheng S, Mikol DD. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.
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.
Ashina 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.
Kudrow 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.
Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Cheng S, Numachi Y, Peng C, Xue F, Mikol DD. Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine. Headache. 2021 Apr;61(4):653-661. doi: 10.1111/head.14096. Epub 2021 Mar 25.
Ashina 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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2012-005331-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120178
Identifier Type: -
Identifier Source: org_study_id
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