A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

NCT02174861 | Completed Phase 2 Results

• 2 other identifiers: 201302552013-005311-27
• Study Type: interventional
• Target: 609
• Locations: 10 countries
• Sites: 65

Brief Summary

To assess the long-term safety and efficacy of erenumab.

Conditions

Treatment for Prevention of Chronic Migraine

Keywords

Chronic Migraine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.

  From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).

• CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use

  At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.

  Day 29 (week 4) and day 57 (week 8) of the substudy

Secondary Outcomes (5)

• Change From Study 20120295 Baseline in Monthly Migraine Days

  4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255

• Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline

  4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255

• Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days

  4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255

• Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours

  4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255

• CHU Substudy: Number of Participants With Adverse Events

  From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.

Study Arms (1)

Erenumab

EXPERIMENTAL

Participants received erenumab 70 mg once a month (QM) or 140 mg QM by subcutaneous injection for up to 52 weeks.

Drug: Erenumab

Interventions

Erenumab DRUG

Administered by subcutaneous injection once a month

Also known as: AMG 334, Aimovig™

Erenumab

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures
• 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.

You may not qualify if:

• Development of any unstable or clinically significant medical condition, laboratory or electrocardiogram (ECG) abnormality following randomization into the parent study, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
• Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1.
• Subject who used excluded concomitant medications between week 8 and week 12 of the parent study

Sponsors & Collaborators

• Amgen: lead

Study Sites (65)

Research Site

Newport Beach, California, 92663, United States

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Palo Alto, California, 94304, United States

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Santa Monica, California, 90404, United States

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Sherman Oaks, California, 91403, United States

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Stamford, Connecticut, 06905, United States

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Jacksonville, Florida, 32256, United States

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Orlando, Florida, 32801, United States

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Palm Beach Gardens, Florida, 33410, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Indianapolis, Indiana, 46256, United States

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Pikesville, Maryland, 21208, United States

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Watertown, Massachusetts, 02472, United States

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Worcester, Massachusetts, 01605, United States

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Ann Arbor, Michigan, 48104, United States

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Springfield, Missouri, 65807, United States

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St Louis, Missouri, 63141, United States

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Reno, Nevada, 89502, United States

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Amherst, New York, 14226, United States

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Greensboro, North Carolina, 27405, United States

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Cleveland, Ohio, 44195, United States

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Philadelphia, Pennsylvania, 19107, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75214, United States

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Dallas, Texas, 75231, United States

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Virginia Beach, Virginia, 23454, United States

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Seattle, Washington, 98195, United States

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Calgary, Alberta, T3M 1M4, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Brno, 611 00, Czechia

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Brno, 656 91, Czechia

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Prague, 120 00, Czechia

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Prague, 140 59, Czechia

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Glostrup Municipality, 2600, Denmark

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Helsinki, 00100, Finland

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Oulu, 90101, Finland

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Tampere, 33100, Finland

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Turku, 20100, Finland

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Berlin, 10117, Germany

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Berlin, 10435, Germany

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Bochum, 44787, Germany

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Essen, 45147, Germany

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Hamburg, 20251, Germany

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Kiel, 24149, Germany

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Ålesund, 6003, Norway

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Lillehammer, 2629, Norway

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Sandvika, 1337, Norway

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Stavanger, 4005, Norway

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Krakow, 31-209, Poland

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Lodz, 90-338, Poland

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Lublin, 20-016, Poland

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Poznan, 60-355, Poland

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Świdnik, 21-040, Poland

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Warsaw, 00-669, Poland

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Falköping, 521 37, Sweden

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Stockholm, 112 45, Sweden

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Stockholm, 114 33, Sweden

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Stockholm, 141 86, Sweden

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Vällingby, 162 68, Sweden

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Glasgow, G51 4TF, United Kingdom

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Hull, HU3 2JZ, United Kingdom

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London, SE5 9RS, United Kingdom

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Stoke-on-Trent, ST4 6QG, United Kingdom

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Related Publications (6)

• 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.

  PMID: 35272533 BACKGROUND

• 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.

  PMID: 31707815 BACKGROUND

• 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.

  PMID: 34928306 DERIVED

• 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.

  PMID: 34301173 DERIVED

• 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.

  PMID: 32216456 DERIVED

• 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.

  PMID: 31852816 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

erenumab

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 26, 2014
• Study Start: June 30, 2014
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: October 12, 2022
• Results First Posted: June 19, 2018

Record last verified: 2022-10

Locations

PL (6); FI (4); GB (4); SE (5); US (29); CA (2); NO (4); DE (6); CZ (4); DK (1)