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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT03096834
First received: March 17, 2017
Last updated: April 20, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have unsuccessfully failed other preventive migraine treatments.

Condition Intervention Phase
Episodic Migraine
Biological: Pre-Filled Syringe (PFS)
Biological: Placebo Pre-Filled Syringe (PFS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Prevention
Official Title: A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed Prophylactic Migraine Treatments

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of patients with a 50% response in the reduction of Monthly Migraine Days (MMD) [ Time Frame: The last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.


Secondary Outcome Measures:
  • Change in the number of monthly migraine days (MMDs) from baseline to month 3 [ Time Frame: Baseline, the last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
  • Change in the Migraine Physical Function Impact Diary (MPFID) "impact on everyday activities" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
  • Change in the MPFID "physical impairment" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
  • Change in the number of monthly acute migraine-specific medication treatment days [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
  • Percentage of patients with a 75% response [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.

  • Percentage of patients with a 100% response [ Time Frame: Baseline, last month (Month 3) of the Double-Blind Treatment Epoch (DBTE) ]
    Assessed via patient report collected in the headache e-diary.


Estimated Enrollment: 220
Actual Study Start Date: March 20, 2017
Estimated Study Completion Date: March 22, 2019
Estimated Primary Completion Date: March 22, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo injection, subcutaneous
Biological: Placebo Pre-Filled Syringe (PFS)
Subcutaneous injection of placebo
Experimental: AMG 334
AMG 334 injection, subcutaneous
Biological: Pre-Filled Syringe (PFS)
subcutaneous injection of AMG 334

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Pregnant or nursing
  • History of cluster or hemiplegic headache
  • Evidence of seizure or psychiatric disorder
  • Score of 19 or higher on BDI
  • Active chronic pain syndrome
  • Cardiac or hepatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03096834

Contacts
Contact: Novartis Pharmaceuticals +41613241111 trialandresults.registries@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Australia
Novartis Investigative Site Recruiting
Heidelberg, Australia, 3084
Austria
Novartis Investigative Site Recruiting
Innsbruck, Austria, A 6020
Novartis Investigative Site Recruiting
Vienna, Austria, 1090
Belgium
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
Novartis Investigative Site Recruiting
Hasselt, Belgium, 3500
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Czechia
Novartis Investigative Site Recruiting
Czech Republic, Czechia, 18600
Finland
Novartis Investigative Site Recruiting
Helsinki, Finland, 00930
Novartis Investigative Site Recruiting
Helsinki, Finland, FI-00100
Novartis Investigative Site Recruiting
Turku, Finland, 20100
France
Novartis Investigative Site Recruiting
Nice, France, 06300
Novartis Investigative Site Recruiting
Paris cedex 10, France, 75010
Germany
Novartis Investigative Site Recruiting
Berlin, Germany, 10435
Novartis Investigative Site Recruiting
Bielefeld, Germany, D 33647
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Leipzig, Germany, 04107
Novartis Investigative Site Recruiting
Muenchen, Germany, 81377
Novartis Investigative Site Recruiting
Wiesbaden, Germany, 65191
Italy
Novartis Investigative Site Recruiting
Milano, Italy, 20133
Norway
Novartis Investigative Site Recruiting
Sandvika, Norway, 1337
United Kingdom
Novartis Investigative Site Recruiting
Brighton, East Sussex, United Kingdom, BN2 5BE
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03096834     History of Changes
Other Study ID Numbers: CAMG334A2301
2016-002211-18 ( EudraCT Number )
Study First Received: March 17, 2017
Last Updated: April 20, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis:
Migraine
attack
headache
episodic
aura
AMG 334
CGRP receptor agonist
erenumab

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 27, 2017