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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03096834 | A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies | PHASE3 | COMPLETED | 246 | — | — | Mar 20, 2017 | Jan 28, 2021 | Mar 23, 2022 | 59 | Australia, Austria +14 |
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo DB | PLACEBO_COMPARATOR | Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch |
| AMG334 140 mg DB | EXPERIMENTAL | AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch |
| AMG334 140 mg DB cont on AMG334 140 mg | EXPERIMENTAL | AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch |
| Placebo in DB to AMG334 140 mg | EXPERIMENTAL | Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch |
| Name | Type | Description |
|---|---|---|
| AMG334 (70 mg) Pre-Filled Syringe (PFS) | BIOLOGICAL | Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection |
| Placebo Pre-Filled Syringe (PFS) | BIOLOGICAL | Subcutaneous injection of matching placebo |
Inclusion Criteria: * Documented history of migraine in the 12 months prior to screen * 4-14 days per month of migraine symptoms * \>=80% diary compliance during the Baseline period * Failure of previous migraine prophylactic treatments Exclusion Criteria: * \>50 years old at migraine onset * Pre...