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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333109
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of AMG334 in countries beyond the United States (US) and European Union (EU).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study uses a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. A screening period of 2 weeks will be used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits will occur at four week intervals until Week 12, which is the End of Treatment visit, Last Patient Last Treatment (LPLT). The final visit, Last Patient Last Visit (LPLV), a Safety Follow-Up visit, will occur 12 weeks later, at Week 24.
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 : November 12, 2019
Actual Study Completion Date : January 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: AMG334 (erenumab) Dose 1
AMG334 Dose 1, administered by pre-filled syringe
 Biological: Erenumab
AMG334 is a fully human monoclonal antibody targeting the CGRP receptor under development for migraine prophylaxis in adults.
Experimental: AMG334 (erenumab) Dose 2
AMG334 Dose 2, administered by pre-filled syringe
 Biological: Erenumab
AMG334 is a fully human monoclonal antibody targeting the CGRP receptor under development for migraine prophylaxis in adults.
Placebo Comparator: Placebo
Placebo administered by pre-filled syringe
 Other: Placebo
Placebo will match the active study drug and will be administered similarly.


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: 3 months ]

Secondary Outcome Measures :
  1. Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3 [ Time Frame: 3 months ]
  2. Change from Baseline in acute migraine-specific medication treatment days at Month 3 [ Time Frame: 3 months ]
  3. Change from Baseline in headache impact scores as measured by the HIT-6 at Month 3 [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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
Last Update Posted: May 1, 2020
Last Verified: April 2020
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 ):
AMG 334, erenumab, migraine, episodic, headache, CGRP
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