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

Treatment for Prevention of Chronic Migraine Clinical Trial

Official title:

An Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 334

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174861
• Other study ID #: 20130255
• Secondary ID: 2013-005311-27
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2014
• Est. completion date: May 26, 2017

Study information

• Verified date: October 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This was a multicenter, 52-week, open-label study designed to assess the long-term safety and efficacy of erenumab in adults with chronic migraine. Participants who completed the 12-week double-blind treatment of the parent Study 20120295 (NCT02066415) and met all Study 20130255 eligibility criteria were eligible for enrollment into this study. Enrollment occurred within 14 days after the parent study's week 12 visit. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 609
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria:

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

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:

1. 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.

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

Related Conditions & MeSH terms

• Migraine Disorders
• Treatment for Prevention of Chronic Migraine

Intervention

Drug:
• Erenumab
Administered by subcutaneous injection once a month

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Montreal	Quebec
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 4
Denmark	Research Site	Glostrup
Finland	Research Site	Helsinki
Finland	Research Site	Oulu
Finland	Research Site	Tampere
Finland	Research Site	Turku
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bochum
Germany	Research Site	Essen
Germany	Research Site	Hamburg
Germany	Research Site	Kiel
Norway	Research Site	Ålesund
Norway	Research Site	Lillehammer
Norway	Research Site	Sandvika
Norway	Research Site	Stavanger
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Swidnik
Poland	Research Site	Warszawa
Sweden	Research Site	Falköping
Sweden	Research Site	Stockholm
Sweden	Research Site	Stockholm
Sweden	Research Site	Stockholm
Sweden	Research Site	Vällingby
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull
United Kingdom	Research Site	London
United Kingdom	Research Site	Stoke on Trent
United States	Research Site	Amherst	New York
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Decatur	Georgia
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Nashville	Tennessee
United States	Research Site	Newport Beach	California
United States	Research Site	Orlando	Florida
United States	Research Site	Palm Beach Gardens	Florida
United States	Research Site	Palo Alto	California
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Pikesville	Maryland
United States	Research Site	Reno	Nevada
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Santa Monica	California
United States	Research Site	Seattle	Washington
United States	Research Site	Sherman Oaks	California
United States	Research Site	Springfield	Missouri
United States	Research Site	Stamford	Connecticut
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Watertown	Massachusetts
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  Finland,  Germany,  Norway,  Poland,  Sweden,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Change From Study 20120295 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 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase.	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
Secondary	Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline	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 4 weeks prior to each study visit.; At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit * 100 / baseline monthly migraine days was less than or equal to -50%.	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
Secondary	Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days	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.	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
Secondary	Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours	The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.; A qualified headache was defined as follows: a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or; a qualified non-migraine headache, which is a headache that lasted continuously for = 4 hours and was not a qualified migraine headache, or; a headache of any duration for which acute headache treatment was administered.	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
Secondary	CHU Substudy: Number of Participants With Adverse Events	Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.; Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms.; An adverse device effect (ADE) is any adverse event related to the use of a medical device.	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.

External Links

•   AmgenTrials clinical trials website