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

ovartis Pharma AG0 sites600 target enrollmentFebruary 25, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders
Sponsor: ovartis Pharma AG
Enrollment: 600
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

February 25, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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:

•\- 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.