| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03832998 | Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine | PHASE3 | COMPLETED | 284 | — | — | Sep 5, 2019 | Jan 7, 2026 | Jan 20, 2026 | 101 | United States, Belgium +11 |
| NCT03836040 | Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine | PHASE3 | ACTIVE NOT_RECRUITING | 457 | — | — | Jul 19, 2019 | Nov 15, 2026 | Dec 23, 2025 | 119 | United States, Belgium +14 |
| NCT03812224 | A Controlled Trial of Erenumab in Migraine Prevention | PHASE3 | COMPLETED | 261 | — | — | Apr 12, 2019 | Nov 25, 2020 | Feb 21, 2024 | 41 | Japan |
| NCT02483585 | Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention | PHASE3 | COMPLETED | 577 | — | — | Jul 20, 2015 | Mar 20, 2017 | Oct 12, 2022 | 76 | United States, Denmark +6 |
| NCT02456740 | Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention | PHASE3 | COMPLETED | 955 | — | — | Jul 17, 2015 | Jun 19, 2017 | Oct 12, 2022 | 129 | United States, Austria +11 |
| NCT02630459 | A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention | PHASE2 | COMPLETED | 475 | — | — | Jan 6, 2016 | Jun 5, 2019 | Oct 12, 2022 | 44 | Japan |
| NCT01952574 | Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention | PHASE2 | COMPLETED | 483 | — | — | Aug 6, 2013 | Nov 12, 2019 | Oct 12, 2022 | 66 | United States, Canada +5 |
| NCT02542605 | To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients | PHASE1 | COMPLETED | 35 | — | — | Nov 11, 2015 | Nov 8, 2017 | Jun 3, 2019 | 3 | United States, Belgium +1 |
| NCT01723514 | Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients | PHASE1 | COMPLETED | 48 | — | — | Nov 14, 2012 | Jul 10, 2014 | Jan 18, 2019 | 1 | Belgium |
| NCT01688739 | Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients | PHASE1 | COMPLETED | 61 | — | — | Mar 13, 2012 | Mar 27, 2013 | Jan 18, 2019 | 1 | Belgium |
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of DBTP.
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, lasting for ≥ 4 hours, and meeting at least 1 of the following criteria: 1. ≥ 2 of the following pain features: * unilateral * throbbing * moderate to severe * exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: * nausea * vomiting * photophobia and phonophobia The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment period minus the number of migraine days during the 4-week baseline period.
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 double-blind treatment phase - the number of migraine days during the 4-week baseline 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 average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
A migraine day was defined as 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 a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. Change from baseline was calculated using the mean monthly migraine days from months 4, 5 and 6 of the DBTP minus the number of migraine days during the 4-week baseline phase. Least squares (LS) mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (current, prior only, or no prior/current treatment), and baseline value as covariates.
On CHU day 29 and day 57, site staff interviewed sub-study participants and asked if they administered a full, partial, or no dose of erenumab (after explaining that a full dose means that the entire volume of the AI/pen was injected) and documented the participant's response in the electronic case report form. Data presented are the percentage of participants who reported "full administration," "not full administration," or "discontinued investigational product (ie, no dose)." (Day 1 of the CHU substudy occurred at any OLTP study visit \[up to week 88\] as long as the participant had previously received at least 1 OL dose of erenumab 140 mg.)
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.
On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion. A MLA was defined as fulfilling 1 of the 2 criteria: 1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia. 2. Headache described as mimicking usual migraine attack treated with triptan.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events. Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life-threatening (places the subject at immediate risk of death) * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.
Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
| Arm | Type | Description |
|---|---|---|
| Dose Level 1 | EXPERIMENTAL | Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2. |
| Dose Level 2 | EXPERIMENTAL | Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2. |
| Placebo | PLACEBO_COMPARATOR | - |
| Erenumab | EXPERIMENTAL | Participants were to receive erenumab 70 mg once a month for 24 weeks during the double-blind treatment period followed by erenumab 70 mg once a month for 28 weeks during the open-label treatment period. |
| Erenumab 70 mg QM | EXPERIMENTAL | Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. |
| Erenumab 140 mg QM | EXPERIMENTAL | Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. |
| Double Blind Treatment Phase (DBTP): Placebo | PLACEBO_COMPARATOR | Participants received placebo by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. |
| DBTP: Erenumab 28 mg QM | EXPERIMENTAL | Participants received erenumab 28 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. |
| DBTP: Erenumab 70 mg QM | EXPERIMENTAL | Participants received erenumab 70 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. |
| DBTP: Erenumab 140 mg QM | EXPERIMENTAL | Participants received erenumab 140 mg by subcutaneous injection on day 1 and at weeks 4, 8, 12, 16, and 20 in the double-blind treatment phase. |
| Open-Label Treatment Phase (OLTP): Erenumab 70-140 mg QM | EXPERIMENTAL | Participants received an erenumab dose of 70 and/or 140 mg QM SC (depending on the participant's visit completion status after Institutional Review Board \[IRB\] approval of Protocol Amendment 2) in the OLTP for a total of 76 weeks. |
| CHU Sub-Study: Two 70 mg/mL AI/pens | EXPERIMENTAL | A subset of participants in the OLTP randomized to self administer erenumab via two 70 mg/mL autoinjector (AI)/pens on day 29 and day 57 of the CHU Sub-Study |
| CHU Sub-Study: One 140 mg/mL AI/pen | EXPERIMENTAL | A subset of participants in the OLTP randomized to self administer erenumab via one 140 mg/mL AI/pen on day 29 and day 57 of the CHU Sub-Study |
| Erenumab 7 mg QM | EXPERIMENTAL | 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. |
| Erenumab 21 mg QM | EXPERIMENTAL | 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. |
| CHU Substudy: Erenumab 140 mg PFS | EXPERIMENTAL | 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). |
| CHU Substudy: Erenumab 140 mg AI/Pen | EXPERIMENTAL | 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). |
| PACAP-38 Challenge Agent | OTHER | In Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B. |
| Name | Type | Description |
|---|---|---|
| Erenumab Dose 1 | DRUG | Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose. |
| Erenumab Dose 2 | DRUG | Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose. |
| Erenumab Dose 3 | DRUG | Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose. |
| Placebo | OTHER | Placebo matching dose for erenumab dose 1, 2 and 3. |
| Erenumab | DRUG | Administered by subcutaneous injection once a month |
| Erenumab PFS | DRUG | Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy |
| Erenumab AI/Pen | DRUG | Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy |
| PACAP-38 Challenge Agent | DRUG | Administered by intravenous infusion during Part A of the study for dose selection for Part B. Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack. |
Inclusion Criteria: * Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study. * Participant's parent or legal representative has provided written informed consent...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 15 | PHASE3 | Atogepant, Topiramate, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1, erenumab-aooe |
| Ki Health Partners. LLC | RVNC | 1 | — | Daxibotulinumtonix A |