CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 246 enrolled
Drug / intervention
AMG334 (70 mg) Pre-Filled Syringe (PFS) +1 morebiological
Likely dose
AMG 334 140 mg subcutaneous injection once monthly (two 70 mg injections)AI-extracted
Key inclusion· 4
  • ✓Documented history of migraine within 12 months before screening
  • ✓4-14 migraine days per month
  • ✓≥80% diary compliance during baseline period
  • ✓Failed previous migraine prophylactic treatments (2-4 prior treatments based on title)
Key exclusion· 7
  • ✕Migraine onset after age 50
  • ✕Pregnant or nursing
  • ✕History of cluster or hemiplegic headache
  • ✕Evidence of seizure or psychiatric disorder

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03096834
NCT03096834Phase 3Completed
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted Mar 30, 2017·Updated Mar 23, 2022

In Brief

A Phase 3 clinical trial evaluating AMG334 (70 mg) Pre-Filled Syringe (PFS) and Placebo Pre-Filled Syringe (PFS) for Episodic Migraine. Completed, enrolled 246 participants across 59 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpisodic Migraine
CountriesAustralia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 30, 2017
Enrollment StartMar 20, 2017
Primary CompletionJan 18, 2018
Study CompletionJan 28, 2021
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.3 years ago

Interventions

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