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Study of Sustained Benefit of Erenumab in Adult Episodic Migraine Patients

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927144
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : August 6, 2020
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Amgen

Brief Summary:
The primary objective is to demonstrate the superiority of subcutaneous erenumab compared to oral prophylactic(s) on sustained benefit defined as % subjects completing one-year on the randomized treatment and achieving at least a 50% reduction from baseline in monthly migraine days at month 12.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Activecontrolled Study Comparing Sustained Benefit of Two Treatment Paradigms (Erenumab qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : November 5, 2021
Estimated Study Completion Date : November 4, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Erenumab
Escalate to Erenumab Dose 2 OR Switch to Oral prophylactic
Drug: Erenumab
Erenumab Dose 1 / Dose 2 Treatment Period 52 weeks

Drug: Oral Prophylactic
SoC oral prophylactic (active comparator) Treatment Period 52 weeks

Active Comparator: Oral Prophylactic
Switch Oral Prophylactic
Drug: Oral Prophylactic
SoC oral prophylactic (active comparator) Treatment Period 52 weeks




Primary Outcome Measures :
  1. Proportion of subjects who complete initially assigned treatment and achieve at least 50% reduction from baseline in monthly migraine days at Month 12 [ Time Frame: Month 12 ]
    To demonstrate the superiority of subcutaneous erenumab compared to oral prophylactic(s) on sustained benefit defined as % subjects completing one-year on the randomized treatment and achieving at least a 50% reduction from baseline in monthly migraine days at month 12.


Secondary Outcome Measures :
  1. Proportion of subjects completing the treatment period at Month 12 on the initially assigned treatment [ Time Frame: Month 12 ]
    To evaluate the effect of erenumab compared to oral prophylactics on overall subject retention defined as % subjects completing treatment period at Month 12 on initially assigned treatment

  2. Cumulative average change from baseline on the monthly migraine days during the treatment period for subjects on the initially assigned treatment (Months 1-12) [ Time Frame: Month 12 ]
    To evaluate the effect of erenumab compared to oral prophylactics on the change from baseline in monthly migraine days during the treatment period

  3. Proportion of responders (PGI-I score greater than or equal to 5) as measured by PGIC at month 12 for subjects completing the treatment period at Month 12 on initially assigned treatment [ Time Frame: Month 12 ]
    To evaluate the effect of erenumab compared to oral prophylactics on the subject's assessment of the change in clinical status since the start of treatment as measured by the Patients' Global Impression of Change (PGIC) Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed
  • Adults greater than or equal to 18 years of age upon entry into screening.
  • Documented history of migraine (with or without aura) greater than or equal to 12 months prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).
  • Greater than or equal to 4 and less than 15 days per month of migraine symptoms (based on ICHD-3 criteria) on average across 3 months prior to screening based on retrospective reporting.
  • Less than 15 days per month of headache symptoms (i.e., migraine and non-migraine).
  • Subjects in need for switching by documented failure of 1 or 2 prophylactic treatments in the last 6 months due to either lack of efficacy or poor tolerability. For subjects with 1 prior treatment failure, the failure should have occurred in the last 6 months. For subjects with 2 prior treatment failures, the second treatment failure should have occurred in the last 6 months.
  • During baseline: Confirmed migraine frequency of 4 to 14 migraine days and less than 15 days of headache symptoms.
  • During baseline: greater than or equal to 80% compliance with the headache diary.

Exclusion Criteria:

  • Subjects meeting any of the following criteria are not eligible for inclusion in this study.

    • Older than 50 years of age at migraine onset.
    • History of cluster headache or hemiplegic migraine headache.
    • Unable to differentiate migraine from other headaches.
    • Lack of efficacy or poor tolerability with greater than 2 treatments from the 7 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial.
  • Efficacy failure is defined as no meaningful reduction in headache frequency, duration, and/or severity after administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on the investigator's assessment.
  • Tolerability failure is defined as documented discontinuation due to adverse events of the respective medication during the last 6 months prior to screening
  • The following scenarios do not constitute lack of therapeutic response:
  • Lack of sustained response to a medication
  • Patient decision to halt treatment due to improvement

    • Used a prohibited medication, device, or procedure within 2 months.
    • Exposure to botulinum toxin in the head and/or neck region within 4 months.
    • Taken the following for any indication in any month during the 2 months prior to the start of the baseline period:
    • Ergotamines or triptans on greater than or equal to 10 days per month, or Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on greater than or equal to 15 days per month, or
    • Opioid- or butalbital-containing analgesics on greater than or equal to 4 days per month.
    • History of major psychiatric disorders (such as schizophrenia or bipolar disorder) or current evidence of depression. Subjects with anxiety disorder and/or major depressive disorders are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months prior to the start of the baseline period.
    • History of seizure disorder or other significant neurological conditions other than migraine. Note: a single childhood febrile seizure is not exclusionary.
    • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
    • History or evidence of any other unstable or clinically significant medical condition or clinically significant vital sign, laboratory, or electrocardiogram (ECG) abnormality during that could pose a risk to subject safety or interfere with the study evaluation.
    • Myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other re-vascularization procedures within 6 months prior to screening.
    • Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
    • Evidence of drug or alcohol abuse or dependence within 12 months.
    • Pregnant or nursing (lactating) women
    • Women of child-bearing potential must use contraception during dosing with study treatment.
    • Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
    • History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
    • Human immunodeficiency virus (HIV) infection by history.
    • Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study).

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): NCT03927144


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Novartis
Investigators
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Study Director: MD Amgen
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03927144    
Other Study ID Numbers: AMG334A2401
2018-001228-20 ( EudraCT Number )
CAMG334A2401 ( Other Identifier: Novartis )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Data sharing for this study is the responsibility of Novartis. 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


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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:
Erenumab
AMG334
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