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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 : July 18, 2019
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 July 18, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date December 4, 2020   (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 Complete list of historical versions of study NCT03927144 on ClinicalTrials.gov Archive Site
Current 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
Original Secondary Outcome Measures  ICMJE Same as current
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 January 15, 2021
Estimated Primary Completion Date December 4, 2020   (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 previous approved prophylactic therapies in the last 6 months due to either lack of efficacy or poor tolerability
  • 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.
  • Failed more than 2 prior migraine prophylaxis (approved) treatments
  • Active chronic pain syndromes (e.g., fibromyalgia, chronic pelvic pain).
  • 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.
  • 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 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 July 2019

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