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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 : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Episodic Migraine Biological: Erenumab Other: Placebo Phase 3

Detailed Description:
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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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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
 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
 Other: Placebo
Matching placebo in pre-filled syringe administered subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. 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:

    1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity
    2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia


Secondary Outcome Measures :
  1. 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:

    1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity
    2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia

  2. 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.

  3. 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


Eligibility Criteria
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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
Criteria

Key inclusion criteria:

  1. Documented history of migraine in the 12 months prior to screening
  2. 4-14 days per month of migraine symptoms
  3. >=80% diary compliance during the Baseline period

Key exclusion criteria:

  1. >50 years old at migraine onset
  2. Pregnant or nursing
  3. History of cluster or hemiplegic headache
  4. Evidence of seizure or major psychiatric disorder
  5. Score of 19 or higher on the BDI
  6. Active chronic pain syndrome
  7. Cardiac or hepatic disease
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] June 7, 2017
Statistical Analysis Plan  [PDF] February 27, 2020

More Information
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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: March 9, 2021
Last Verified: March 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

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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
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AMG334
erenumab
episodic migraine
headache
 CGRP
Calcitonin Gene-related
migraine
adult
Additional relevant MeSH terms:
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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