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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 2, 2019
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 : December 4, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

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 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

  2. 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

  3. 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



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 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).

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

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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     History of Changes
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: July 2, 2019
Last Verified: July 2019
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
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors