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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06241313 | Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine | PHASE3 | ACTIVE NOT_RECRUITING | 1,300 | — | — | Mar 25, 2024 | Nov 1, 2026 | May 27, 2026 | 149 | Belgium, China +13 |
| NCT05748483 | Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine | PHASE3 | ACTIVE NOT_RECRUITING | 545 | — | — | Oct 7, 2023 | May 1, 2026 | May 25, 2025 | 81 | Austria, Belgium +10 |
| NCT05861427 | Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine | PHASE3 | COMPLETED | 523 | — | — | Jul 12, 2023 | Mar 1, 2025 | Mar 17, 2025 | 48 | Japan |
| NCT04818515 | Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine | PHASE1 | COMPLETED | 26 | — | — | Mar 17, 2021 | Jun 18, 2021 | Jun 16, 2022 | 3 | United States |
Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when Ubrogepant is administered.
Area Under the Plasma Concentration-time Curve from 0 to t (AUC0-t), when ubrogepant and atogepant are coadministered.
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when Ubrogepant is administered.
Area Under the Plasma Concentration-time Curve from 0 to infinity (AUC0-inf), when ubrogepant and atogepant are coadministered.
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when Atogepant is administered.
Area Under the Plasma Concentration-time Curve during the dosing interval at steady state (AUCtau), when ubrogepant and atogepant are coadministered.
Maximum plasma drug concentration (Cmax) when ubrogepant is administered.
Maximum plasma drug concentration (Cmax) when atogepant is administered.
Maximum plasma drug concentration (Cmax) of ubrogepant when ubrogepant and atogepant are coadministered.
Maximum plasma drug concentration (Cmax) of atogepant when ubrogepant and atogepant are coadministered.
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | PLACEBO_COMPARATOR | Participants will receive both atogepant and placebo to treat qualifying migraines. |
| Sequence 2 | EXPERIMENTAL | Participants will receive both atogepant and placebo to treat qualifying migraines. |
| Sequence 3 | EXPERIMENTAL | Participants will receive both atogepant and placebo to treat qualifying migraines. |
| Sequence 4 | EXPERIMENTAL | Participants will receive both atogepant and placebo to treat qualifying migraines. |
| Atogepant | EXPERIMENTAL | Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period. |
| Topiramate | ACTIVE_COMPARATOR | Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period. |
| Atogepant Dose A | EXPERIMENTAL | Participants will receive atogepant dose A once daily (QD) for 24 weeks. |
| Atogepant Dose B | EXPERIMENTAL | Participants will receive atogepant dose B QD for 24 weeks. |
| Atogepant Dose C | EXPERIMENTAL | Participants will receive atogepant dose C QD for 24 weeks. |
| Placebo | EXPERIMENTAL | Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks. |
| Atogepant, Ubrogepant, and Coadministration | EXPERIMENTAL | Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant, followed by administration of oral tablets of atogepant and ubrogepant in combination, for a 30 day interventional period and a 7 day follow up period. |
| Name | Type | Description |
|---|---|---|
| Atogepant | DRUG | Oral Tablet |
| Placebo for Atogepant | DRUG | Oral Tablet |
| Topiramate | DRUG | Oral Capsule |
| Placebo for Topiramate | DRUG | Oral Capsule |
| Ubrogepant | DRUG | Oral; Tablet |
Inclusion Criteria: * History of migraine (with or without aura) according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) for \>= 12 months prior to Visit 1/Screening. * History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months pr...
| 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 |