Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients (EMPOwER)
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ClinicalTrials.gov Identifier: NCT03333109 |
Recruitment Status :
Completed
First Posted : November 6, 2017
Results First Posted : March 9, 2021
Last Update Posted : October 11, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Episodic Migraine | Biological: Erenumab Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 900 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER) |
Actual Study Start Date : | February 8, 2018 |
Actual Primary Completion Date : | January 13, 2020 |
Actual Study Completion Date : | January 13, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: AMG334 70 mg
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
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Biological: Erenumab
70 mg/mL pre-filled syringe administered subcutaneously
Other Name: AMG334 |
Experimental: AMG334 140 mg
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
|
Biological: Erenumab
70 mg/mL pre-filled syringe administered subcutaneously
Other Name: AMG334 |
Placebo Comparator: Placebo
Two pre-filled syringes containing placebo identical in appearance to erenumab
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Other: Placebo
Matching placebo in pre-filled syringe administered subcutaneously |
- Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) [ Time Frame: Baseline up to Month 3 ]
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
- ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity
- ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
- Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3 [ Time Frame: Baseline and at Month 3 ]
Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria:
- ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity
- ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
- Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3 [ Time Frame: Baseline up to 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 include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.
- Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3 [ Time Frame: Baseline up to Month 3 ]The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key inclusion criteria:
- Documented history of migraine in the 12 months prior to screening
- 4-14 days per month of migraine symptoms
- >=80% diary compliance during the Baseline period
Key exclusion criteria:
- >50 years old at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder
- Score of 19 or higher on the BDI
- Active chronic pain syndrome
- Cardiac or hepatic disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333109

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03333109 |
Other Study ID Numbers: |
CAMG334A2302 |
First Posted: | November 6, 2017 Key Record Dates |
Results First Posted: | March 9, 2021 |
Last Update Posted: | October 11, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
URL: | https://www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
AMG334 erenumab episodic migraine headache |
CGRP Calcitonin Gene-related migraine adult |
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Erenumab |
Calcitonin Gene-Related Peptide Receptor Antagonists Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |