Approval Probability
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Adjusted LOA
ML Risk
AMG334 Pre-Filled Syringe · 1 trial · 1 indication
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...
AMG334 Pre-Filled Syringe is being developed for the prevention of episodic migraine in adults. It is a monoclonal antibody administered by injection and is intended for patients with episodic migraine, including those who have not responded to other preventive therapies.
AMG334 Pre-Filled Syringe is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating this monoclonal antibody formulation for episodic migraine prevention.
AMG334 Pre-Filled Syringe is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 3 trial evaluating it has been completed, and no active trials for this formulation are currently listed.
AMG334 Pre-Filled Syringe was evaluated in the Phase 3 trial NCT03096834, titled A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies. The trial enrolled 246 adults with episodic migraine across sites in Australia and multiple European countries and has been completed.
The Phase 3 trial NCT03096834 was a randomized, double-blind, placebo-controlled study of 246 adults aged 18 years and older with episodic migraine. It enrolled both sexes and excluded healthy volunteers, and it was conducted across Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom.