Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI0618 · 1 trial · 1 indication
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 | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
MEDI0618 is an investigational small molecule being developed for the treatment of episodic migraine. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MEDI0618 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
MEDI0618 is in Phase 2 clinical development. It is an investigational drug and has not yet been approved for commercial use.
MEDI0618 is being studied in a Phase 2 clinical trial with the identifier NCT06602479. This trial is recruiting participants and is designed to evaluate the safety and efficacy of MEDI0618 compared to placebo in adults with episodic migraine.
Yes, the Phase 2 trial of MEDI0618 is a randomized, double-blind, placebo-controlled study. It is actively recruiting approximately 488 participants across multiple countries, including the United States, Czechia, Denmark, Germany, Hungary, Italy, Poland, and Spain.