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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06602479 | A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine | PHASE2 | RECRUITING | 488 | — | — | Oct 7, 2024 | May 7, 2027 | May 19, 2026 | 54 | United States, Czechia +6 |
Change in number of MHDs from 4-week baseline to last 4 weeks of treatment period.
| Arm | Type | Description |
|---|---|---|
| aCGRP-N_MEDI0618 (Dose A) | EXPERIMENTAL | In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo. After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each. |
| aCGRP-N_Placebo | PLACEBO_COMPARATOR | In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo. After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each. |
| aCGRP-N_MEDI0618 (Dose B) | EXPERIMENTAL | After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm. |
| aCGRP-N_MEDI0618 (Dose C) | EXPERIMENTAL | After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm. |
| aCGRP-N_MEDI0618 (Dose D) | EXPERIMENTAL | After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm. |
| aCGRP-IR_MEDI0618 (Dose A) | EXPERIMENTAL | In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo). |
| aCGRP-IR_Placebo | PLACEBO_COMPARATOR | In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo). |
| Name | Type | Description |
|---|---|---|
| MEDI0618 | DRUG | MEDI0618 per protocol |
| Placebo | DRUG | Volume-matched placebo for all arms |
Inclusion Criteria: * 18 to 70 years of age * Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2. * History of migraine headaches with or without aura, with migraine onset at ≤ 50 years of age and for at least 12 months prior to screening. * At least 12 MHDs over the last 3 months prior to screening. * Participan...
| 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 |