Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MAP0004 · 1 trial · 1 indication
Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| Arm | Type | Description |
|---|---|---|
| MAP0004 | EXPERIMENTAL | MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. |
| Placebo | OTHER | Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks. |
| Name | Type | Description |
|---|---|---|
| MAP0004 | DRUG | MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only. |
| Placebo | DRUG | Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks. |
Major Inclusion Criteria: * Male or female between 18 and 65 years of age. * History of episodic, acute migraine (with or without aura) with onset prior to 50 Major Exclusion Criteria: * Known allergy or sensitivity or contraindication to study drugs or their formulations * History of chronic pul...
MAP0004 is an investigational small molecule being developed for the treatment of migraine disorders in adults. It is a Phase 3 candidate from AbbVie Inc. (ticker: ABBV) and has been studied in a completed Phase 3 trial in adult migraineurs.
MAP0004 is being developed by AbbVie Inc., which trades under the ticker ABBV. The company is responsible for the clinical program in migraine disorders.
MAP0004 is in Phase 3 development for migraine disorders. It is an investigational therapy and has not been approved by the FDA. One Phase 3 trial has been completed, and no active trials are currently listed.
MAP0004 has been evaluated in a completed Phase 3 trial, NCT00623636, titled Phase 3 Study of MAP0004 in Adult Migraineurs. The trial enrolled 902 participants, was randomized, double-blind, and controlled, and was conducted in the United States.
MAP0004 is not approved by the FDA. It remains an investigational therapy in Phase 3 clinical development for migraine disorders, with one completed Phase 3 trial and no active trials listed.