Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine

Detailed Description
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This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.

Official Title
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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)

Conditions
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Episodic Migraine

Intervention / Treatment
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* Biological: Erenumab
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG334 70 mg<br>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 | Biological: Erenumab<br>* 70 mg/mL pre-filled syringe administered subcutaneously<br>* Other names: AMG334;|
| Experimental: AMG334 140 mg<br>AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days | Biological: Erenumab<br>* 70 mg/mL pre-filled syringe administered subcutaneously<br>* Other names: AMG334;|
| Placebo Comparator: Placebo<br>Two pre-filled syringes containing placebo identical in appearance to erenumab | Other: Placebo<br>* Matching placebo in pre-filled syringe administered subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) | 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 | Baseline up to Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days 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 | Baseline and at Month 3 | 
| Change From Baseline in 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 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. | Baseline up to Month 3 | 
| Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at 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 | Baseline up to Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMG334, erenumab, episodic migraine, headache, CGRP, Calcitonin Gene-related, migraine, adult