A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms in adult episodic migraine patients

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 600

Inclusion Criteria

- Adults =18 of age upon entry into screening.
- Documented history of migraine (with or without aura) =12 months
prior to screening.
- =4 and <15 days per month of migraine symptoms (based on ICHD-3
criteria) on average across 3 months prior to screening based on
retrospective reporting.
- <15 days per month of headache symptoms (i.e., migraine and nonmigraine)
?
- Subjects in need for switching by documented failure of 1 or 2
prophylactic therapies in the last 6 months due to either lack of efficacy
or poor tolerability (see list of prophylactic therapies in Exclusion
Criteria 6 and definition for lack of efficacy and 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 period, confirmed migraine frequency of 4 to 14
migraine days and <15 days of headache symptoms.
- During baseline period, =80% compliance with the headache diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Older than 50 years of age at migraine onset.
Lack of efficacy or poor tolerability with > 2 treatments from the
following 7 medication categories for prophylactic treatment of migraine
after an adequate therapeutic trial. These medication categories are:
Category 1: Divalproex sodium, sodium valproate, Category 2:
Topiramate, Category 3: Beta blockers, Category 4: Tricyclic
antidepressants, Category 5: Serotonin-norepinephrine reuptake
inhibitors, Category 6: Flunarizine, verapamil, Category 7: Lisinopril,
candesartan
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 start of and during
baseline for a non-migraine indication if dose is not stable.
- 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 = 10 days per month, or
?-- Simple analgesics (non-steroidal anti-inflammatory drugs [NSAIDs],
acetaminophen) on = 15 days per month, or
?-- Opioid- or butalbital-containing analgesics on =4 days per month
- Device, or procedure that potentially may interfere with the intensity or
number of migraine days within 2 months prior to the start of or during
baseline
- Previous exposure to erenumab or exposure to any other prophylactic
CGRP-targeted therapy prior to the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 4/30/2019

A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms in adult episodic migraine patients

Recruitment & Eligibility

Study & Design

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