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Study of Sustained Benefit of Erenumab in Adult Episodic Migraine Patients

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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

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date November 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2019)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Proportion of subjects completing the study at Month 12 on the randomized treatment [ Time Frame: Month 12 ]
    To evaluate the effect of erenumab compared to oral prophylactic(s) on overall subject retention defined as % subjects completing study on randomized treatment
  • Cumulative average change from baseline on the monthly migraine days during the treatment period (Months 1-12) [ Time Frame: Month 12 ]
    To evaluate the effect of erenumab compared to oral prophylactic(s) on the change from baseline in monthly migraine days during the treatment period
  • Proportion of responders as measured by PGIC at month 12 on the randomized treatment [ Time Frame: Month 12 ]
    To evaluate the effect of erenumab compared to oral prophylactic(s) 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sustained Benefit of Erenumab in Adult Episodic Migraine Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Episodic Migraine
Intervention  ICMJE
  • Drug: Erenumab
    Erenumab Dose 1 / Dose 2 Treatment Period 52 weeks
  • Drug: Oral Prophylactic
    SoC oral prophylactic (active comparator) Treatment Period 52 weeks
Study Arms  ICMJE
  • Experimental: Erenumab
    Escalate to Erenumab Dose 2 OR Switch to Oral prophylactic
    Interventions:
    • Drug: Erenumab
    • Drug: Oral Prophylactic
  • Active Comparator: Oral Prophylactic
    Switch Oral Prophylactic
    Intervention: Drug: Oral Prophylactic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 4, 2022
Estimated Primary Completion Date November 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Czechia,   Finland,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Netherlands,   Poland,   Portugal,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927144
Other Study ID Numbers  ICMJE AMG334A2401
2018-001228-20 ( EudraCT Number )
CAMG334A2401 ( Other Identifier: Novartis )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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

Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Novartis
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP