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AMG 301 · 1 trial · 1 indication
A migraine day is any calendar day from the eDiary in which the participant experienced a migraine headache. A migraine headache is a headache with or without aura, lasting for \>= 4 hours, and meeting \>=1 of the criteria: 1. \>= 2 pain features (unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity) 2. \>= 1 symptoms (nausea and/or vomiting, photophobia and phonophobia) If the participant took a migraine-specific medication during aura or to treat headache, it was counted as a migraine day. Days without eDiary data in each monthly interval are handled by proration. Negative change from baseline values indicated improvement (i.e. fewer migraine days after treatment as compared to baseline).
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period. |
| AMG 301 210 mg Q4W | EXPERIMENTAL | Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period. |
| AMG 301 420 mg Q2W | EXPERIMENTAL | Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days. |
| AMG 301 | DRUG | AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days. |
Inclusion Criteria: * Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form. * History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of ...
AMG 301 is an investigational small molecule being studied for the prevention of chronic migraine or episodic migraine. It is being developed by Amgen Inc. and is intended for patients with these migraine conditions.
AMG 301 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being investigated for its potential to prevent migraines, though the exact mechanism of action is not publicly detailed.
AMG 301 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate the drug's efficacy and safety in migraine prevention.
AMG 301 is in Phase 2 clinical development. It has completed a Phase 2 trial, and it remains an investigational drug, not yet approved by regulatory authorities. Further studies may be needed to establish its safety and efficacy.
AMG 301 has been studied in one completed Phase 2 clinical trial, identified as NCT03238781. This randomized, double-blind, placebo-controlled trial enrolled 343 participants with chronic or episodic migraine across multiple countries, including the United States, Austria, Canada, Czechia, Denmark, Finland, Germany, and Sweden.
AMG 301 is not known to be the same as any other drug, as no alternative names have been reported. It is a distinct investigational compound being developed by Amgen Inc. for migraine prevention.