Treatment for Prevention of Chronic MigrainePhase 2NCT02066415
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
A Phase 2 study testing Erenumab in people with Treatment for Prevention of Chronic Migraine, run by Amgen at 74 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment for Prevention of Chronic Migraine
- What is being tested?
- Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 667 participants
- Where
- 74 sitesin 10 countries
- Study dates
- 5 Mar 2014to 28 Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
74 sites in 10 countries.
74 sites in 10 countries
United States34 sites
Research Site
Amherst, New York, 14226
Research Site
Ann Arbor, Michigan, 48104
Research Site
Atlanta, Georgia, 30342
Research Site
Austin, Texas, 78731
Research Site
Cleveland, Ohio, 44195
Research Site
Dallas, Texas, 75214
Research Site
Dallas, Texas, 75231
Research Site
Decatur, Georgia, 30033
Research Site
Greensboro, North Carolina, 27405
Research Site
Indianapolis, Indiana, 46256
Research Site
Jacksonville, Florida, 32256
Research Site
Kalamazoo, Michigan, 49009
Research Site
La Jolla, California, 92037
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Nashville, Tennessee, 37203
Research Site
Newport Beach, California, 92663
Research Site
Orlando, Florida, 32801
Research Site
Palm Beach Gardens, Florida, 33410
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Pikesville, Maryland, 21208
Research Site
Reno, Nevada, 89502
Research Site
San Francisco, California, 94109
Research Site
Santa Monica, California, 90404
Research Site
Seattle, Washington, 98195-6169
Research Site
Sherman Oaks, California, 91403
Research Site
Springfield, Missouri, 65807
Research Site
St Louis, Missouri, 63141
Research Site
Stamford, Connecticut, 06905
Research Site
Stanford, California, 94305
Research Site
Temple, Texas, 76508
Research Site
Virginia Beach, Virginia, 23454
Research Site
Watertown, Massachusetts, 02472
Research Site
West Palm Beach, Florida, 33407
Research Site
Worcester, Massachusetts, 01605
Poland8 sites
Research Site
Krakow, 31-209
Research Site
Lodz, 90-338
Research Site
Lublin, 20-016
Research Site
Poznan, 60-355
Research Site
Świdnik, 21-040
Research Site
Warsaw, 00-669
Research Site
Warsaw, 01-192
Research Site
Warsaw, 04-052
Germany7 sites
Research Site
Berlin, 10117
Research Site
Berlin, 10435
Research Site
Bochum, 44787
Research Site
Essen, 45147
Research Site
Hamburg, 20251
Research Site
Kiel, 24149
Research Site
Königstein im Taunus, 61462
Finland5 sites
Research Site
Helsinki, 00100
Research Site
Jyväskylä, 40100
Research Site
Oulu, 90101
Research Site
Tampere, 33100
Research Site
Turku, 20100
Sweden5 sites
Research Site
Falköping, 521 37
Research Site
Stockholm, 112 45
Research Site
Stockholm, 114 33
Research Site
Stockholm, 141 86
Research Site
Vällingby, 162 68
Czechia4 sites
Research Site
Brno, 611 00
Research Site
Brno, 656 91
Research Site
Prague, 120 00
Research Site
Prague, 140 59
Norway4 sites
Research Site
Ålesund, 6003
Research Site
Lillehammar, 2629
Research Site
Sandvika, 1337
Research Site
Stavanger, 4005
United Kingdom4 sites
Research Site
Glasgow, G51 4TF
Research Site
Hull, HU3 2JZ
Research Site
London, SE5 9RS
Research Site
Stoke-on-Trent, ST4 6QG
Canada2 sites
Research Site
Calgary, Alberta, T3M 1M4
Research Site
Montreal, Quebec, H2L 4M1
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
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.
Read the 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).
- Being tested
- Erenumab, Placebo
- Keywords
- Chronic Migraine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabBiological
Also called AMG 334, Aimovig™
Administered once a month subcutaneously by authorized investigational site study staff.
PlaceboDrug
Administered once a month subcutaneously by authorized investigational site study staff.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. Receives: Drug: Placebo |
| Erenumab 70 mg | Experimental | Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. Receives: Biological: Erenumab |
| Erenumab 140 mg | Placebo comparator | Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. Receives: Biological: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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%.
Measured: 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
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.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
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.
Measured: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
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.
Measured: 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
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.
Measured: Baseline and weeks 2, 4, 8, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start5 Mar 2014
- Primary completion24 Feb 2016
- Study completion28 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Treatment for Prevention of Chronic MigraineStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066415
- Sponsor's protocol ID
- 20120295
- Other IDs
- 2013-001707-36
- Status last verified
- Oct 2022
- First submitted
- 17 Feb 2014
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28460892Cheng 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.
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.
PubMed 35272533Ashina 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.
PubMed 31707815Kudrow 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.
PubMed 31852816Lipton 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.
PubMed 33982623Lipton 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.
PubMed 34407654Lipton 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.
PubMed 30996060Lipton 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.
PubMed 33269951Tepper 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.
PubMed 30996056Lampl 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.
PubMed 35978286Ashina 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.
PubMed 34928306Tepper 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.
PubMed 34301173Brandes 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.
PubMed 31816249
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
- ClinicalTrials.gov ID
- NCT02066415
- Acronym / sponsor ID
- 20120295
- Keywords
- Chronic Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2014 (actual)
- Primary completion
- 24 Feb 2016 (actual)
- Study completion
- 28 Apr 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 21 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection. |
| Erenumab 70 mg | Experimental | Biological: ErenumabParticipants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. |
| Erenumab 140 mg | Placebo comparator | Biological: ErenumabParticipants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErenumabAlso: AMG 334, Aimovig™Administered once a month subcutaneously by authorized investigational site study staff. | Biological | Erenumab 140 mg, Erenumab 70 mg |
| PlaceboAdministered once a month subcutaneously by authorized investigational site study staff. | Drug | Placebo |
Primary outcome
Change From Baseline in Monthly Migraine Days
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
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.
5 secondary outcomes
Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline
Time frame: 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
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Change From Baseline in Cumulative Monthly Headache Hours
Time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase
Number of Participants With Adverse Events
Time frame: 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
Time frame: Baseline and weeks 2, 4, 8, 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28460892Tepper 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.
- BackgroundCheng 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: PubMed 35272533Zhou 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.
- Background: PubMed 31707815Ashina 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.
- Background: PubMed 31852816Kudrow 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.
- Background: PubMed 33982623Lipton 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.
- Background: PubMed 34407654Lipton 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.
- Background: PubMed 30996060Lipton 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.
- Background: PubMed 33269951Lipton 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.
- Background: PubMed 30996056Tepper 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.
- Derived from this study: PubMed 35978286Lampl 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.
- Derived from this study: PubMed 34928306Ashina 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
74 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erenumab in people with Treatment for Prevention of Chronic Migraine, run by Amgen at 74 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Poland, Germany, Finland, Sweden and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Monthly Migraine Days (time frame: 4-week baseline phase and the last 4 weeks of the 12-week treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066415, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.