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

NCT04825678 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20190389
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 42

Brief Summary

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

Conditions

Migraine

Keywords

Migraine; Chronic Migraine; Episodic Migraine; Erenumab

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC

  The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.

  Baseline and Week 24

• Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type

  The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.

  Baseline and Week 24

Secondary Outcomes (10)

• Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC

  Week 24

• GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC

  Baseline up to Week 24

• Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type

  Week 24

• GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type

  Baseline up to Week 24

• Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC

  Baseline and Week 24

Study Arms (1)

Erenumab

EXPERIMENTAL

Drug: Erenumab

Interventions

Erenumab DRUG

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

Also known as: AMG 334

Erenumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (42)

Rehabilitation and Neurological Services LLC

Huntsville, Alabama, 35805, United States

Location

Elite Clinical Studies LLC

Phoenix, Arizona, 85018, United States

Location

Neurology Center of North Orange County

Fullerton, California, 92835, United States

Location

The Neurology Group

Pomona, California, 91767, United States

Location

Mountain Neurological Research Center

Basalt, Colorado, 81621, United States

Location

Mindscapes Counseling, LLC

Norwich, Connecticut, 06360, United States

Location

Reliable Clinical Research, LLC

Hialeah, Florida, 33012, United States

Location

Homestead Associates In Research Inc

Homestead, Florida, 33032, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

The Community Research of South Florida

Miami Lakes, Florida, 33016, United States

Location

Research Institute of Orlando

Orlando, Florida, 32806, United States

Location

Pas Research

Tampa, Florida, 33613, United States

Location

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, 30060, United States

Location

Chicago Headache Center and Research Institute

Chicago, Illinois, 60657, United States

Location

College Park Family Care Center

Overland Park, Kansas, 66212, United States

Location

Family HealthCare

Germantown, Maryland, 20876, United States

Location

Neurology Center of New England

Foxborough, Massachusetts, 02035, United States

Location

ActivMed Practices and Research, LLC

Lowell, Massachusetts, 01852, United States

Location

Memorial Healthcare Foundation

Owosso, Michigan, 48867, United States

Location

SRI International

Plymouth, Michigan, 48170, United States

Location

Citizens Memorial Healthcare

Bolivar, Missouri, 65613, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65807, United States

Location

Psych Care Consultants

St Louis, Missouri, 63128, United States

Location

Albuquerque Clinical Trials Inc

Albuquerque, New Mexico, 87102, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Dent Neurosciences Research Center

Amherst, New York, 14226, United States

Location

Northwell Health Physician Partners Neuroscience Institute at Great Neck

Great Neck, New York, 11021, United States

Location

Island Neurological Associates

Plainview, New York, 11803, United States

Location

Nuvance Health Medical Practice Primary Care Division of Neurology

Poughkeepsie, New York, 12601, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Asheville Neurology Specialists PA

Asheville, North Carolina, 28806, United States

Location

Onsite Clinical Solutions LLC

Charlotte, North Carolina, 28277, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Saint Lukes Neurology Associates

Bethlehem, Pennsylvania, 18018, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, United States

Location

Premier Neurology

Greer, South Carolina, 29650, United States

Location

Tri-State Mountain Neurology Associates

Johnson City, Tennessee, 37604, United States

Location

Pearland Neurology Services PLLC

Houston, Texas, 77089, United States

Location

Protenium Clinical Research

Hurst, Texas, 76054, United States

Location

Houston Neurology Associates

Sugar Land, Texas, 77478, United States

Location

Sugar Lakes Family Practice

Sugar Land, Texas, 77479, United States

Location

Vaught Neurological Services

Crab Orchard, West Virginia, 25827, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: June 11, 2021
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (42)