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

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: NCT04825678
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : October 6, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.

Condition or disease Intervention/treatment Phase
Migraine Drug: Erenumab Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine
Actual Study Start Date : June 11, 2021
Actual Primary Completion Date : September 28, 2023
Actual Study Completion Date : September 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Erenumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Erenumab Drug: Erenumab
Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
Other Name: AMG 334


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 [ Time Frame: Baseline and Week 24 ]
    As measured by items 12 to 14 of the TSQM version 1.4. Items 12 and 13 measure confidence in benefits and balance between good and bad things on a 5 point rating scale where 1 indicates least satisfaction and 5 indicates most satisfaction. Item 14 measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction.


Secondary Outcome Measures :
  1. Number of Participants Achieving Overall Satisfaction at Week 24 [ Time Frame: Week 24 ]
    Overall satisfaction is defined by participant reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction.

  2. Number of Participants Reporting Improvement in Participant Global Impression at Week 24 [ Time Frame: Week 24 ]
    Improvement is defined by participant reporting of much improved or a little improved on the migraine Global Impression Item (mGI-I).

  3. Number of Clinician's Reporting Improvement in Treating Clinician's Global Impression at Week 24 [ Time Frame: Week 24 ]
    Improvement is defined by treating clinician's reporting of much improved or a little improved on the mGI-I for each individual participant.

  4. Number of Key Family Member's Reporting Improvement in Key Family Member's Impression at Week 24 [ Time Frame: Week 24 ]
    Improvement is defined by key family member's reporting of much improved or a little improved on the mGI-I for each individual participant.

  5. Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 [ Time Frame: Baseline and Week 24 ]
  6. Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24 [ Time Frame: Baseline and Week 24 ]
  7. Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24 [ Time Frame: Baseline and Week 24 ]
  8. Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24 [ Time Frame: Baseline and Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT04825678


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04825678    
Other Study ID Numbers: 20190389
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: October 6, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Migraine
Chronic Migraine
Episodic Migraine
Erenumab
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