Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05550207 | Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE) | PHASE3 | COMPLETED | 100 | — | — | Aug 31, 2022 | Nov 27, 2024 | Dec 2, 2025 | 31 | United States |
| NCT04163185 | Initiating Early Control of Migraine Pain and Associated Symptoms | PHASE3 | COMPLETED | 302 | — | — | Oct 8, 2019 | Mar 23, 2020 | Jan 28, 2026 | 41 | United States |
| NCT04068051 | Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT) | PHASE3 | COMPLETED | 706 | — | — | Jul 6, 2019 | Sep 22, 2020 | Oct 10, 2023 | 51 | United States |
| NCT03896009 | Maximizing Outcomes in Treating Acute Migraine | PHASE3 | COMPLETED | 1,594 | — | — | Mar 4, 2019 | Dec 10, 2019 | Aug 24, 2023 | 85 | United States |
Absence of headache pain and without the use of rescue medication.
Absence of the most bothersome symptom, defined at the onset of migraine.
Absence of headache pain at Hour 2
Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2
Long-term safety as measured by: Subjects with any TEAEs Subjects with suspected to be drug-related TEAEs Subjects with serious TEAEs Subjects with TEAEs that led to drug withdrawal Subjects with TEAEs that led to withdrawal from study Subjects with TEAEs that resulted in death
Absence of headache pain. AXS-07 vs Placebo.
Absence of most bothersome symptom, defined at the onset of migraine. AXS-07 vs Placebo.
| Arm | Type | Description |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | EXPERIMENTAL | Up to 8 weeks |
| AXS-07 | EXPERIMENTAL | Taken once upon migraine |
| Placebo | PLACEBO_COMPARATOR | Taken once upon migraine |
| Meloxicam | ACTIVE_COMPARATOR | Taken once upon a qualifying migraine |
| Rizatriptan | ACTIVE_COMPARATOR | Taken once upon a qualifying migraine |
| Name | Type | Description |
|---|---|---|
| AXS-07 (meloxicam-rizatriptan) | DRUG | AXS-07 tablets, taken orally for the acute treatment of migraine |
| AXS-07 (MoSEIC meloxicam and rizatriptan) | DRUG | AXS-07 tablet taken once upon the earliest onset of migraine pain. |
| Placebo | DRUG | Placebo tablet taken once upon the earliest onset of migraine pain. |
| AXS-07 | DRUG | AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. |
| Meloxicam | DRUG | Meloxicam taken once upon onset of a qualifying migraine. |
| Rizatriptan | DRUG | Rizatriptan taken once upon onset of a qualifying migraine. |
Inclusion Criteria: * Has an established diagnosis of migraine with or without aura * Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine Exclusion Criteria: * Pregnant, breastfeeding, or planning to become pregnant during the study * Has previously ...
| 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 |