APPRAISE 12 Month Study of Erenumab vs Prophylactics in Migraine

  • Research type

    Research Study

  • Full title

    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

  • IRAS ID

    263749

  • Contact name

    Giorgio Lambru

  • Contact email

    Giorgio.Lambru@gstt.nhs.uk

  • Sponsor organisation

    Novartis Pharma Services AG

  • Eudract number

    2018-001228-20

  • Duration of Study in the UK

    1 years, 7 months, 13 days

  • Research summary

    Migraine is one of the most common neurological disorders with a high global prevalence, significant socio-economic burden and substantial impairment and disability of affected patients. It is mainly characterized by recurrent headache lasting 4-72 hours and is usually accompanied by other neurological disturbances, nausea, and vomiting.
    “Episodic migraine” is characterized by the presence of up to 14 migraine days per months. Migraine patients are currently being treated prophylactically by a variety of drug classes, many of them being used off-label and often based on insufficient or limited evidence. Common prophylactic drugs or drug classes used include beta-blockers, anti-epileptic agents, antidepressants, certain calcium channel blockers, and certain angiotensinconverting- enzyme inhibitor/angiotensin II receptor blockers. All of these therapies are commonly associated with either insufficient efficacy and/or substantial tolerability issues that often leads to treatment discontinuation in migraine patients.
    The standard of care also varies significantly across different geographies and treatment decisions are often made on a case-by-case basis without consensus on treatment guidelines.
    Based on emerging evidence, calcitonin gene-related peptide (CGRP) is a neuropeptide that prominently contributes to migraine pathophysiology. Erenumab (AMG334) is a monoclonal antibody targeting the CGRP receptor, that is administered once monthly via subcutaneous injection. Given the emerging erenumab clinical profile including the available data in treatment failure patients, one key question is if early use of erenumab is associated with a favorable long-term sustained benefit and how erenumab compares with oral prophylactics over one year in a real world setting.
    This is a 12 month, randomized, active controlled study comparing sustained benefit of erenumab vs. oral prophylactics in adult episodic migraine patients
    The study is being conducted globally with 600 patients to be randomized. In the UK we are expecting 56 patients across 9 sites.

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    19/SC/0256

  • Date of REC Opinion

    19 Sep 2019

  • REC opinion

    Further Information Favourable Opinion