NCT03096834

A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments (LIBERTY)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.

Detailed description

This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.

Conditions

• Episodic Migraine

Interventions

Type	Name	Description
BIOLOGICAL	AMG334 (70 mg) Pre-Filled Syringe (PFS)	Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection
BIOLOGICAL	Placebo Pre-Filled Syringe (PFS)	Subcutaneous injection of matching placebo

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-01-18
• Completion: 2021-01-28
• First posted: 2017-03-30
• Last updated: 2022-03-23
• Results posted: 2022-02-18

Locations

59 sites across 16 countries: Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study