A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

NCT02066415 | Completed Phase 2 Results DMC

• 2 other identifiers: 201202952013-001707-36
• Study Type: interventional
• Target: 667
• Locations: 10 countries
• Sites: 74

Brief Summary

To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.

Conditions

Treatment for Prevention of Chronic Migraine

Keywords

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Monthly Migraine Days

  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 treatment phase - the number of migraine days during the 4-week baseline phase.

  4-week baseline phase and the last 4 weeks of the 12-week treatment phase

Secondary Outcomes (5)

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

  4-week baseline phase and the last 4 weeks of the 12-week treatment phase

• Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days

  4-week baseline phase and the last 4 weeks of the 12-week treatment phase

• Change From Baseline in Cumulative Monthly Headache Hours

  4-week baseline phase and the last 4 weeks of the 12-week treatment phase

• Number of Participants With Adverse Events

  From the first dose of study drug up to 16 weeks after the last dose (24 weeks)

• Number of Participants Who Developed Antibodies to Erenumab

  Baseline and weeks 2, 4, 8, 12 and 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.

Drug: Placebo

Erenumab 70 mg

EXPERIMENTAL

Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.

Biological: Erenumab

Erenumab 140 mg

PLACEBO COMPARATOR

Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.

Biological: Erenumab

Interventions

Erenumab BIOLOGICAL

Administered once a month subcutaneously by authorized investigational site study staff.

Also known as: AMG 334, Aimovig™

Erenumab 140 mg; Erenumab 70 mg

Placebo DRUG

Administered once a month subcutaneously by authorized investigational site study staff.

Placebo

Eligibility Criteria

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

You may qualify if:

• History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
• History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
• ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
• Demonstrated at least 80% compliance with the eDiary.

You may not qualify if:

• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• Failed \> 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
• Received botulinum toxinin head or neck region within 4 months prior to screening.
• Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase

Sponsors & Collaborators

• Amgen: lead

Study Sites (74)

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La Jolla, California, 92037, United States

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Newport Beach, California, 92663, United States

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San Francisco, California, 94109, 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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Stanford, California, 94305, 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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Kalamazoo, Michigan, 49009, 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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Temple, Texas, 76508, United States

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Virginia Beach, Virginia, 23454, United States

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Seattle, Washington, 98195-6169, United States

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Milwaukee, Wisconsin, 53226, 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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Jyväskylä, 40100, 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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Königstein im Taunus, 61462, Germany

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Ålesund, 6003, Norway

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Lillehammar, 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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Warsaw, 01-192, Poland

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Warsaw, 04-052, 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 (14)

• Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jun;16(6):425-434. doi: 10.1016/S1474-4422(17)30083-2. Epub 2017 Apr 28.

  PMID: 28460892 BACKGROUND

• 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.

  BACKGROUND

• 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

• 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 BACKGROUND

• Lipton RB, Burstein R, Buse DC, Dodick DW, Koukakis R, Klatt J, Cheng S, Chou DE. Efficacy of erenumab in chronic migraine patients with and without ictal allodynia. Cephalalgia. 2021 Oct;41(11-12):1152-1160. doi: 10.1177/03331024211010305. Epub 2021 May 13.

  PMID: 33982623 BACKGROUND

• Lipton RB, Dodick DW, Kudrow D, Reuter U, Tenenbaum N, Zhang F, Lima GPDS, Chou DE, Mikol DD. Reduction in migraine pain intensity in patients treated with erenumab: A post hoc analysis of two pivotal randomized studies. Cephalalgia. 2021 Dec;41(14):1458-1466. doi: 10.1177/03331024211028966. Epub 2021 Aug 18.

  PMID: 34407654 BACKGROUND

• Lipton RB, Tepper SJ, Reuter U, Silberstein S, Stewart WF, Nilsen J, Leonardi DK, Desai P, Cheng S, Mikol DD, Lenz R. Erenumab in chronic migraine: Patient-reported outcomes in a randomized double-blind study. Neurology. 2019 May 7;92(19):e2250-e2260. doi: 10.1212/WNL.0000000000007452. Epub 2019 Apr 17.

  PMID: 30996060 BACKGROUND

• Lipton RB, Tepper SJ, Silberstein SD, Kudrow D, Ashina M, Reuter U, Dodick DW, Zhang F, Rippon GA, Cheng S, Mikol DD. Reversion from chronic migraine to episodic migraine following treatment with erenumab: Results of a post-hoc analysis of a randomized, 12-week, double-blind study and a 52-week, open-label extension. Cephalalgia. 2021 Jan;41(1):6-16. doi: 10.1177/0333102420973994. Epub 2020 Dec 3.

  PMID: 33269951 BACKGROUND

• Tepper SJ, Diener HC, Ashina M, Brandes JL, Friedman DI, Reuter U, Cheng S, Nilsen J, Leonardi DK, Lenz RA, Mikol DD. Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology. 2019 May 14;92(20):e2309-e2320. doi: 10.1212/WNL.0000000000007497. Epub 2019 Apr 17.

  PMID: 30996056 BACKGROUND

• Lampl 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.

  PMID: 35978286 DERIVED

• 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

• Brandes JL, Diener HC, Dolezil D, Freeman MC, McAllister PJ, Winner P, Klatt J, Cheng S, Zhang F, Wen S, Ritter S, Lenz RA, Mikol DD. The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving >/=50%, >/=75%, and 100% response. Cephalalgia. 2020 Jan;40(1):28-38. doi: 10.1177/0333102419894559. Epub 2019 Dec 9.

  PMID: 31816249 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

erenumab

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Study Start: March 5, 2014
• Primary Completion: February 24, 2016
• Study Completion: April 28, 2016
• Last Updated: October 12, 2022
• Results First Posted: June 21, 2018

Record last verified: 2022-10

Locations

NO (4); SE (5); FI (5); CZ (4); GB (4); US (34); CA (2); DE (7); DK (1); PL (8)