Trial ID or NCT#
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.
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
- - 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.
- - 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 from the 7 categories of prior prophylactic medications within 3 months prior to the start of and during baseline for a non-migraine indication if dose is not stable - 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. - Device, or procedure that potentially may interfere with the intensity or number of migraine days within 2 months. - 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. - 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, based on Investigator discretion 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. - Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy (prior to the study).
Contact us to find out if this trial is right for you.