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

Primary Purpose

Episodic Migraine

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AMG334 (70 mg) Pre-Filled Syringe (PFS)

Placebo Pre-Filled Syringe (PFS)

About this trial

This is an interventional prevention trial for Episodic Migraine focused on measuring Migraine, attack, headache, episodic, aura, AMG 334, CGRP receptor agonist, erenumab, adult

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 over 19 on Beck Depression Inventory-2
Active chronic pain syndrome
Cardiac or hepatic disease

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo DB

AMG334 140 mg DB

AMG334 140 mg DB cont on AMG334 140 mg

Placebo in DB to AMG334 140 mg

Arm Description

Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch

AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch

Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch

Outcomes

Primary Outcome Measures

Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)

A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.

Secondary Outcome Measures

Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)

Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3

MPFID has 2 domains: Everyday Activities, which consisted of 7 items and Physical Impairment with 5 items using a 5-point scale. Scores were summed across each domain and were then transformed and used for analyses. Transforming MPFID domain scores ranged from 0-100, where higher scores were indicative of greater migraine impact (ie, higher burden)

Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3

Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications included two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline was the number of migraine-specific medication treatment days in the baseline period.

Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)

Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)

Number of Participants Who Developed Anti-AMG334 Antibodies

Blood samples for immunogenicity testing were collected for the measurement of anti-AMG334 binding antibodies.

Full Information

NCT ID

NCT03096834

First Posted

March 17, 2017

Last Updated

February 23, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03096834

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

March 20, 2017 (Actual)

Primary Completion Date

January 18, 2018 (Actual)

Study Completion Date

January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Episodic Migraine

Keywords

Migraine, attack, headache, episodic, aura, AMG 334, CGRP receptor agonist, erenumab, adult

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo DB

Arm Type

Placebo Comparator

Arm Description

Matching placebo subcutaneous injections administered every 4 weeks during Double-Blind Epoch

Arm Title

AMG334 140 mg DB

Arm Type

Experimental

Arm Description

AMG334 70 mg subcutaneous injections (2) administered every 4 weeks during Double-Blind Epoch

Arm Title

AMG334 140 mg DB cont on AMG334 140 mg

Arm Type

Experimental

Arm Description

AMG334 70 mg subcutaneous injections (2) during DB continued on AMG334 140 mg in Open-Label Epoch

Arm Title

Placebo in DB to AMG334 140 mg

Arm Type

Experimental

Arm Description

Placebo in Double-Blind Epoch (DB) switched to AMG334 140 mg in Open-Label Epoch

Intervention Type

Biological

Intervention Name(s)

AMG334 (70 mg) Pre-Filled Syringe (PFS)

Intervention Description

Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection

Intervention Type

Biological

Intervention Name(s)

Placebo Pre-Filled Syringe (PFS)

Intervention Description

Subcutaneous injection of matching placebo

Primary Outcome Measure Information:

Title

Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)

Description

Time Frame