A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms (erenumab qm vs. oral prophylactics) in adult episodic migraine patients
- Conditions
- 10019231HeadacheMigraine
- Registration Number
- NL-OMON55516
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
- 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 non-migraine)
- 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. 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.
- 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: 1: Divalproex
sodium, sodium valproate, 2: Topiramate, 3: Beta blocker , 4: Tricyclic
antidepressants, 5: Serotonin-norepinephrine reuptake inhibitors, 6:
Flunarizine, verapamil, 7: Lisinopril, candesartan
- Used a prohibited medication, device, or procedure within 2 months prior to
the start of or during baseline or during the treatment period.
- Exposure to botulinum toxin in the head and/or neck region within 4 months
prior to the start of the baseline period, during the baseline period, or
treatment period.
- 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, or
- Device, or procedure that potientially may interfere with the intensity or
number of migraine days
- Previous exposure to erenumab or exposure to any other prophylactic
CGRP-targeted therapy (prior to and during the study).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to demonstrate the superiority of subcutaneous<br /><br>erenumab compared to oral prophylactic(s) on sustained benefit defined as %<br /><br>subjects completing one-year on the randomized treatment and achieving at least<br /><br>a 50% reduction from baseline in monthly migraine days at month 12.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are the following:<br /><br>Objective 1: To evaluate the effect of erenumab compared to oral<br /><br>prophylactic(s) on overall subject retention defined as % subjects completing<br /><br>study on randomized treatment<br /><br>Objective 2: To evaluate the effect of erenumab compared to oral<br /><br>prophylactic(s) on the change from baseline in monthly migraine days during the<br /><br>treatment period<br /><br>Objective 3: To evaluate the effect of erenumab compared to oral<br /><br>prophylactic(s) on the subject's assessment of the change in clinical status<br /><br>since the start of treatment as measured by the Patients' Global Impression of<br /><br>Change (PGIC) Scale</p><br>