A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

NCT ID: NCT04825678

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2023-09-28

Brief Summary

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The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Erenumab

Group Type EXPERIMENTAL

Erenumab

Intervention Type DRUG

Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).

Interventions

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Erenumab

Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).

Intervention Type DRUG

Other Intervention Names

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AMG 334

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Participant has provided informed consent
* History of migraine (with or without aura) for ≥ 12 months before screening
* ≥ 4 migraine days per month on average across the 3 months prior to screening
* Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
* Participant reports to their provider intolerance or insufficient response with their current preventative treatment

Exclusion Criteria

* History of cluster headache or hemiplegic migraine headache
* Unable to differentiate migraine from other headaches
* Evidence of substance-related disorders
* Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
* No therapeutic response with \> 3 migraine preventive medication categories
* Used a prohibited medication, device, or procedure
* Other clinically significant disorder, condition, or disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Rehabilitation and Neurological Services LLC

Huntsville, Alabama, United States

Site Status

Elite Clinical Studies LLC

Phoenix, Arizona, United States

Site Status

Neurology Center of North Orange County

Fullerton, California, United States

Site Status

The Neurology Group

Pomona, California, United States

Site Status

Mountain Neurological Research Center

Basalt, Colorado, United States

Site Status

Mindscapes Counseling, LLC

Norwich, Connecticut, United States

Site Status

Reliable Clinical Research, LLC

Hialeah, Florida, United States

Site Status

Homestead Associates In Research Inc

Homestead, Florida, United States

Site Status

New Age Medical Research Corporation

Miami, Florida, United States

Site Status

The Community Research of South Florida

Miami Lakes, Florida, United States

Site Status

Research Institute of Orlando

Orlando, Florida, United States

Site Status

Pas Research

Tampa, Florida, United States

Site Status

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, United States

Site Status

Chicago Headache Center and Research Institute

Chicago, Illinois, United States

Site Status

College Park Family Care Center

Overland Park, Kansas, United States

Site Status

Family HealthCare

Germantown, Maryland, United States

Site Status

Neurology Center of New England

Foxborough, Massachusetts, United States

Site Status

ActivMed Practices and Research, LLC

Lowell, Massachusetts, United States

Site Status

Memorial Healthcare Foundation

Owosso, Michigan, United States

Site Status

SRI International

Plymouth, Michigan, United States

Site Status

Citizens Memorial Healthcare

Bolivar, Missouri, United States

Site Status

Clinvest Research LLC

Springfield, Missouri, United States

Site Status

Psych Care Consultants

St Louis, Missouri, United States

Site Status

Albuquerque Clinical Trials Inc

Albuquerque, New Mexico, United States

Site Status

Albany Medical College

Albany, New York, United States

Site Status

Dent Neurosciences Research Center

Amherst, New York, United States

Site Status

Northwell Health Physician Partners Neuroscience Institute at Great Neck

Great Neck, New York, United States

Site Status

Island Neurological Associates

Plainview, New York, United States

Site Status

Nuvance Health Medical Practice Primary Care Division of Neurology

Poughkeepsie, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Asheville Neurology Specialists PA

Asheville, North Carolina, United States

Site Status

Onsite Clinical Solutions LLC

Charlotte, North Carolina, United States

Site Status

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Site Status

Saint Lukes Neurology Associates

Bethlehem, Pennsylvania, United States

Site Status

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Site Status

Premier Neurology

Greer, South Carolina, United States

Site Status

Tri-State Mountain Neurology Associates

Johnson City, Tennessee, United States

Site Status

Pearland Neurology Services PLLC

Houston, Texas, United States

Site Status

Protenium Clinical Research

Hurst, Texas, United States

Site Status

Houston Neurology Associates

Sugar Land, Texas, United States

Site Status

Sugar Lakes Family Practice

Sugar Land, Texas, United States

Site Status

Vaught Neurological Services

Crab Orchard, West Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20190389

Identifier Type: -

Identifier Source: org_study_id

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