A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.
NCT ID: NCT02174861
Last Updated: 2022-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
609 participants
INTERVENTIONAL
2014-06-30
2017-05-26
Brief Summary
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Detailed Description
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The initial dose used in the study was erenumab 70 mg every month (QM). The protocol was subsequently amended to increase the dose to erenumab 140 mg QM (Protocol Amendment 2). Participants who had already completed the week 28 visit (ie, midpoint of the study) at the time of Protocol Amendment 2 continued to receive open-label erenumab 70 mg QM for the remainder of the study. Participants who enrolled but had not completed the week 28 visit at the time of Protocol Amendment 2 increased the open-label erenumab dose from 70 mg QM to 140 mg QM at the next visit. All participants who enrolled after Protocol Amendment 2 received open-label erenumab 140 mg QM throughout the study.
Participants may elect to participate in a separate clinical home use (CHU) substudy to assess subjects' ability to self-administer 140 mg of erenumab for in-home use using either two prefilled syringes (PFS) or two prefilled autoinjector/pens (AI/pens). Enrollment in the 12-week substudy occurred at either week 12 or week 40 of study 20130255. Participants were randomized to self-administer erenumab using either the PFS or AI/pen on CHU days 29 and 57 at home.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Erenumab
Participants received erenumab 70 mg once a month (QM) or 140 mg QM by subcutaneous injection for up to 52 weeks.
Erenumab
Administered by subcutaneous injection once a month
Interventions
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Erenumab
Administered by subcutaneous injection once a month
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 (NCT02066415) parent study, and is appropriate for continued treatment.
Exclusion Criteria
2. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1.
3. Subject who used excluded concomitant medications between week 8 and week 12 of the parent study
18 Years
66 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
Newport Beach, California, United States
Research Site
Palo Alto, California, United States
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Santa Monica, California, United States
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Sherman Oaks, California, United States
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Stamford, Connecticut, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Palm Beach Gardens, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Indianapolis, Indiana, United States
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Pikesville, Maryland, United States
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Watertown, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Amherst, New York, United States
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Greensboro, North Carolina, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Virginia Beach, Virginia, United States
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Seattle, Washington, United States
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Calgary, Alberta, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Glostrup Municipality, , Denmark
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Helsinki, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Turku, , Finland
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Ålesund, , Norway
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Lillehammer, , Norway
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Sandvika, , Norway
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Stavanger, , Norway
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Świdnik, , Poland
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Warsaw, , Poland
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Falköping, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Vällingby, , Sweden
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Glasgow, , United Kingdom
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Hull, , United Kingdom
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London, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
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.
Tepper SJ, Ashina M, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Picard H, Cheng S, Chou DE, Zhang F, Klatt J, Mikol DD. Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials. J Headache Pain. 2021 Jul 23;22(1):81. doi: 10.1186/s10194-021-01292-w.
Tepper SJ, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein SD, Winner P, Zhang F, Cheng S, Mikol DD. Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. Cephalalgia. 2020 May;40(6):543-553. doi: 10.1177/0333102420912726. Epub 2020 Mar 26.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-005311-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130255
Identifier Type: -
Identifier Source: org_study_id
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