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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Episodic Migraine	Biological: Pre-Filled Syringe (PFS); Biological: Placebo Pre-Filled Syringe (PFS)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (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
Actual Study Start Date :	March 20, 2017
Actual Primary Completion Date :	January 18, 2018
Estimated Study Completion Date :	January 19, 2021

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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) ]
2. 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 ]
3. Change in the MPFID "physical impairment" domain score from baseline to month 3 [ Time Frame: Baseline, month 3 of the DBTE ]
4. 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) ]
5. 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.
6. 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.

Eligibility Criteria

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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

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Contacts

Contact: Novartis Pharmaceuticals	+41613241111	novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

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Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT03096834 History of Changes
Other Study ID Numbers:	CAMG334A2301; 2016-002211-18 ( EudraCT Number )
First Posted:	March 30, 2017
Last Update Posted:	May 1, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
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 ( Novartis Pharmaceuticals ):

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