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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)
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.
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Heidelberg, Australia
Novartis Investigative Site
Innsbruck, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Ghent, Belgium
Novartis Investigative Site
Hasselt, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Prague, CZE, Czechia
Novartis Investigative Site
Czech Republic, Czechia
Novartis Investigative Site
Prague, Czechia
Start Date
March 20, 2017
Primary Completion Date
January 18, 2018
Completion Date
January 28, 2021
Last Updated
March 23, 2022
246
ACTUAL participants
AMG334 (70 mg) Pre-Filled Syringe (PFS)
BIOLOGICAL
Placebo Pre-Filled Syringe (PFS)
BIOLOGICAL
Lead Sponsor
Novartis Pharmaceuticals
NCT06248671
NCT03432286
NCT05207865
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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