- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01952574
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 12-week double-blind treatment phase (DBTP), an open-label treatment phase (OLTP) for up to 256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational product [IP]).
In the DBTP participants were to be randomized in a 3:2:2:2 ratio to placebo, erenumab 7 mg, erenumab 21 mg, or erenumab 70 mg.
During the open-label treatment phase, participants were to receive erenumab 70 mg QM from week 12 to week 264. After implementation of Protocol Amendment 3 (07 April 2016), participants remaining in the OLTP increased their dose to erenumab 140 mg QM up to week 264. The safety follow-up increased from an 8-week safety follow-up to a 12-week safety follow-up (16 weeks after the last dose of investigational product).
During the OLTP participants enrolled at sites in the United States could enroll in an optional clinical home use (CHU) substudy, per a country-specific protocol amendment dated 20 June 2016. Participants in the CHU substudy were to be randomized 1:1 into 1 of 2 treatment groups: erenumab 140 mg using a prefilled syringe or erenumab 140 mg using an autoinjector/pen. Day 1 of the CHU substudy corresponded with any OLTP study visit up through Week 256, as long as the participant had received at least 2 doses of erenumab 140 mg. During the CHU substudy, participants initially self-administered IP under site supervision on substudy day 1, and then self-administered IP at home on substudy days 29 and 57.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4S 1Y2
- Research Site
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
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Aarhus C, Denmark, 8000
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Glostrup, Denmark, 2600
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Helsinki, Finland, 00100
- Research Site
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Mikkeli, Finland, 50100
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Oulu, Finland, 90220
- Research Site
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Tampere, Finland, 33100
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Turku, Finland, 20100
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Berlin, Germany, 10117
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Berlin, Germany, 10409
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Berlin, Germany, 10435
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Bochum, Germany, 44789
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Essen, Germany, 45133
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Hamburg, Germany, 20246
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Leipzig, Germany, 04107
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Hamar, Norway, 2317
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Sandvika, Norway, 1337
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Stavanger, Norway, 4005
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Ålesund, Norway, 6003
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Falköping, Sweden, 521 37
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Lund, Sweden, 222 22
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Stockholm, Sweden, 112 45
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Stockholm, Sweden, 114 33
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Vällingby, Sweden, 162 68
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Arizona
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Phoenix, Arizona, United States, 85032
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California
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Long Beach, California, United States, 90806
- Research Site
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National City, California, United States, 91950
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Newport Beach, California, United States, 92663
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San Francisco, California, United States, 94109
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Santa Monica, California, United States, 90404
- Research Site
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Sherman Oaks, California, United States, 91403
- Research Site
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Spring Valley, California, United States, 91978
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Connecticut
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Danbury, Connecticut, United States, 06810
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Fairfield, Connecticut, United States, 06824
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Stamford, Connecticut, United States, 06905
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Florida
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Bradenton, Florida, United States, 34205
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Melbourne, Florida, United States, 32935
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Palm Beach Gardens, Florida, United States, 33410
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West Palm Beach, Florida, United States, 33407
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Georgia
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Decatur, Georgia, United States, 30033
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Kansas
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Wichita, Kansas, United States, 67207
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Kentucky
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Lexington, Kentucky, United States, 40513
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Louisville, Kentucky, United States, 40213
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Massachusetts
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Watertown, Massachusetts, United States, 02472
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Worcester, Massachusetts, United States, 01605
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Michigan
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Ann Arbor, Michigan, United States, 48104
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Kalamazoo, Michigan, United States, 49009
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Southfield, Michigan, United States, 48034
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Minnesota
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Plymouth, Minnesota, United States, 55441
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Missouri
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Saint Louis, Missouri, United States, 63141
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Springfield, Missouri, United States, 65807
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New York
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Rochester, New York, United States, 14609
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North Carolina
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Greensboro, North Carolina, United States, 27405
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Raleigh, North Carolina, United States, 27612
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
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Tennessee
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Nashville, Tennessee, United States, 37203
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Texas
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Arlington, Texas, United States, 76017
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Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75231
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Dallas, Texas, United States, 75214
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Houston, Texas, United States, 77074
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Utah
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Salt Lake City, Utah, United States, 84124
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Salt Lake City, Utah, United States, 84106
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Virginia
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Falls Church, Virginia, United States, 22042
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Virginia Beach, Virginia, United States, 23454
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- History of migraine for more than12 months prior to screening
- Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
- Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase
- Demonstrated at least 80% compliance with the eDiary during baseline phase
Exclusion Criteria:
- Older than 50 years of age at migraine onset
- History of cluster headache or basilar or hemiplegic migraine headache
- Unable to differentiate migraine from other headaches
No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:
- Category 1: Divalproex sodium, sodium valproate
- Category 2: Topiramate
- Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
- Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
- Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
- Category 6: Flunarizine, verapamil
- Category 7: Lisinopril, candesartan
- Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)
- Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM. |
Administered by study site staff once a month (QM) as a subcutaneous injection
Other Names:
Administered by study site staff once a month (QM) as a subcutaneous injection
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Experimental: Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM. |
Administered by study site staff once a month (QM) as a subcutaneous injection
Other Names:
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Experimental: Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM. |
Administered by study site staff once a month (QM) as a subcutaneous injection
Other Names:
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Experimental: Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection during the double-blind treatment phase. In the open-label treatment phase participants received 70 mg erenumab QM from week 12 to week 264 (last dose). After Protocol Amendment 3, participants still on study had their dose increased to 140 mg QM. |
Administered by study site staff once a month (QM) as a subcutaneous injection
Other Names:
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Experimental: CHU Substudy: Erenumab 140 mg PFS
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using a prefilled syringe (PFS) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
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Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
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Experimental: CHU Substudy: Erenumab 140 mg AI/Pen
Participants in the open-label treatment phase in the United States randomized to self-administer 140 mg erenumab via two 70 mg injections using an autoinjector/pen (AI)/pen) on CHU substudy day 1 (under study site supervision), and at home on day 29 (week 4) and day 57 (week 8).
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Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Monthly Migraine Days at Week 12
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
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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 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 double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
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4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
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CHU Substudy: Number of Participants Who Self-administered a Full Dose, Partial Dose, or No Dose of Erenumab
Time Frame: CHU substudy day 29 (week 4) and day 57 (week 8)
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To assess participants ability to administer a full dose of erenumab in home-use at day 29 (week 4) and day 57 (week 8), site staff called participants and asked whether the participant administered a full, partial, or no dose of erenumab.
A full dose means that the entire volume of both prefilled syringes or autoinjector/pens were injected.
Discontinued prior to dosing day indicates participants who had discontinued the investigational product and did not attempt to self-administer on day 29 or 57.
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CHU substudy day 29 (week 4) and day 57 (week 8)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
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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 double-blind 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 double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.
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4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
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Change From Baseline in Monthly Migraine Attacks at Week 12
Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
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A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack. The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase. |
4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
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Number of Participants With Treatment-emergent Adverse Events in the Double-blind Treatment Phase
Time Frame: From first dose of study drug in the double-blind treatment phase until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase.
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An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
A serious adverse event is an AE that meets at least 1 of the following criteria:
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From first dose of study drug in the double-blind treatment phase until the first dose of study drug in the open-label treatment phase (12 weeks) or up to 12 weeks after last dose for participants who did not enter the open-label treatment phase.
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Number of Participants With Treatment-emergent Adverse Events in the Open-label Treatment Phase
Time Frame: From first dose in the open-label treatment phase up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; a maximum of 268 weeks.
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An adverse event (AE) is any untoward medical occurrence in a clinical trial subject, including worsening of a pre-existing medical condition and laboratory value changes that require treatment or adjustment in current therapy. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
A serious adverse event is an AE that meets at least 1 of the following criteria:
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From first dose in the open-label treatment phase up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; a maximum of 268 weeks.
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CHU Substudy: Number of Participants With Treatment-emergent Adverse Events During the CHU Substudy
Time Frame: From first dose in the CHU substudy to end of substudy (up to 12 weeks)
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AEs were graded using the CTCAE version 4.03:
A serious adverse event is an AE that meets at least 1 of the following criteria:
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From first dose in the CHU substudy to end of substudy (up to 12 weeks)
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Number of Participants Who Developed Anti-erenumab Antibodies During the Double-blind Treatment Phase
Time Frame: 12 weeks
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Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative or had no result at baseline but positive at any time postbaseline during the DBTP. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies. |
12 weeks
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Number of Participants Who Developed Anti-erenumab Antibodies During the Open-label Treatment Phase
Time Frame: From week 12 up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks.
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Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding erenumab. Second, a cell-based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. Participants who developed anti-erenumab antibodies are participants who were negative prior to the first OLTP dose but positive at any time during the OLTP, or participants with no data prior to first dose in OLTP with any post-baseline positive results. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies. |
From week 12 up to 12 weeks (participants receiving 70 mg only) or 16 weeks (participants with dose increased to 140 mg) after the last dose; maximum 268 weeks.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F, Zhang F, Paiva da Silva Lima G, Cheng S, Mikol DD. Long-term efficacy and safety of erenumab in migraine prevention: Results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol. 2021 May;28(5):1716-1725. doi: 10.1111/ene.14715. Epub 2021 Jan 20.
- Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick D, Rippon GA, Klatt J, Xue F, Chia V, Zhang F, Cheng S, Mikol DD. Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. Cephalalgia. 2019 Oct;39(11):1455-1464. doi: 10.1177/0333102419854082. Epub 2019 May 30.
- 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.
- Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Cheng S, Numachi Y, Peng C, Xue F, Mikol DD. Long-term efficacy and safety during open-label erenumab treatment in Japanese patients with episodic migraine. Headache. 2021 Apr;61(4):653-661. doi: 10.1111/head.14096. Epub 2021 Mar 25.
- Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M, Saper J, Cady R, Chon Y, Dietrich J, Lenz R. Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):382-90. doi: 10.1016/S1474-4422(16)00019-3. Epub 2016 Feb 12.
- Ashina M, Dodick D, Goadsby PJ, Reuter U, Silberstein S, Zhang F, Gage JR, Cheng S, Mikol DD, Lenz RA. Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. Neurology. 2017 Sep 19;89(12):1237-1243. doi: 10.1212/WNL.0000000000004391. Epub 2017 Aug 23.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Immunologic Factors
- Calcitonin Gene-Related Peptide Receptor Antagonists
- Antibodies, Monoclonal
- Erenumab
Other Study ID Numbers
- 20120178
- 2012-005331-90 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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