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

Phase 1

• Conditions: Migraine prevention; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-001228-20-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 5 April 2021

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 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 (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 (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine, duloxetine, milnacipran)
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