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-IT
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-28
• Last Update Posted: 7 December 2020

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 previous approved prophylactic therapies in the last 6 months due to either lack of efficacy or poor tolerability out of the following: Beta-blockers; Topiramate; Valproate/divalproex; Amitriptyline, nortriptyline Flunarizine; Other locally approved migraine prophylactic medications (e.g. oxeterone, pizotifen)
- 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 0

Exclusion Criteria

- Older than 50 years of age at migraine onset.
- Failed more than 2 prior migraine prophylaxis (approved) treatments
- 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
- Previous exposure to erenumab or exposure to any other prophylactic CGRP-targeted therapy (prior to and during the study).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified