NCT03238781

Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

Detailed description

A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.

Conditions

• Chronic Migraine or Episodic Migraine

Interventions

Type	Name	Description
DRUG	Placebo	Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.
DRUG	AMG 301	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.

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-10-16
• Completion: 2019-02-04
• First posted: 2017-08-03
• Last updated: 2020-02-07
• Results posted: 2020-02-07

Locations

49 sites across 8 countries: United States, Austria, Canada, Czechia, Denmark, Finland, Germany, Sweden

Regulatory

• FDA-regulated drug study