Back to resultsA Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
Primary Purpose
Treatment for Prevention of Chronic Migraine
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Erenumab
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Treatment for Prevention of Chronic Migraine focused on measuring Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Placebo
Erenumab 70 mg
Erenumab 140 mg
Arm Description
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From 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 last 4 weeks of treatment.
At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Change From 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.
Change From 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.
Number of Participants With Adverse Events
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:
Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.
Number of Participants Who Developed Antibodies to Erenumab
Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).
Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02066415
Brief Title
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2014 (Actual)
Primary Completion Date
February 24, 2016 (Actual)
Study Completion Date
April 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy.
Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment for Prevention of Chronic Migraine
Keywords
Chronic Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
667 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
Arm Title
Erenumab 70 mg
Arm Type
Experimental
Arm Description
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Arm Title
Erenumab 140 mg
Arm Type
Placebo Comparator
Arm Description
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
Intervention Type
Biological
Intervention Name(s)
Erenumab
Other Intervention Name(s)
AMG 334, Aimovig™
Intervention Description
Administered once a month subcutaneously by authorized investigational site study staff.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered once a month subcutaneously by authorized investigational site study staff.
Primary Outcome Measure Information:
Title
Change From Baseline in Monthly Migraine Days
Description
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.
Time Frame
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline
Description
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 last 4 weeks of treatment.
At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
Time Frame
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Title
Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days
Description
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.
Time Frame
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Title
Change From Baseline in Cumulative Monthly Headache Hours
Description
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.
Time Frame
4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Title
Number of Participants With Adverse Events
Description
Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:
Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE.
Time Frame
From the first dose of study drug up to 16 weeks after the last dose (24 weeks)
Title
Number of Participants Who Developed Antibodies to Erenumab
Description
Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).
Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.
If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.
Time Frame
Baseline and weeks 2, 4, 8, 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Research Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Research Site
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Research Site
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Research Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Research Site
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Research Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Research Site
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6169
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
611 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Research Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Research Site
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
Facility Name
Research Site
City
Oulu
ZIP/Postal Code
90101
Country
Finland
Facility Name
Research Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Research Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10435
Country
Germany
Facility Name
Research Site
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
Research Site
City
Königstein im Taunus
ZIP/Postal Code
61462
Country
Germany
Facility Name
Research Site
City
Lillehammar
ZIP/Postal Code
2629
Country
Norway
Facility Name
Research Site
City
Sandvika
ZIP/Postal Code
1337
Country
Norway
Facility Name
Research Site
City
Stavanger
ZIP/Postal Code
4005
Country
Norway
Facility Name
Research Site
City
Ålesund
ZIP/Postal Code
6003
Country
Norway
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-016
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Research Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
00-669
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-052
Country
Poland
Facility Name
Research Site
City
Falköping
ZIP/Postal Code
521 37
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
112 45
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
114 33
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Research Site
City
Vällingby
ZIP/Postal Code
162 68
Country
Sweden
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Research Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Research Site
City
Stoke on Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28460892
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
35272533
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.
Results Reference
background
PubMed Identifier
31707815
Citation
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.
Results Reference
background
PubMed Identifier
31852816
Citation
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. Erratum In: Neurology. 2020 Jun 9;94(23):1052.
Results Reference
background
PubMed Identifier
33982623
Citation
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.
Results Reference
background
PubMed Identifier
34407654
Citation
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.
Results Reference
background
PubMed Identifier
30996060
Citation
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.
Results Reference
background
PubMed Identifier
33269951
Citation
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.
Results Reference
background
PubMed Identifier
30996056
Citation
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.
Results Reference
background
PubMed Identifier
35978286
Citation
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.
Results Reference
derived
PubMed Identifier
34928306
Citation
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.
Results Reference
derived
PubMed Identifier
34301173
Citation
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.
Results Reference
derived
PubMed Identifier
31816249
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
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