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Feasibility study of a randomised controlled trial to investigate the treatment of sarcoidosis-associated fatigue with methylphenidate (FaST-MP): a study protocol
  1. Christopher Atkins1,2,
  2. Richard Fordham1,
  3. Allan B Clark1,
  4. Andrea Stockl1,
  5. Andrew P Jones1,
  6. Andrew M Wilson1,2
  1. 1 Department of Medicine, University of East Anglia Norwich Medical School, Norwich, Norfolk, UK
  2. 2 Department of Respiratory Medicine, Norfolk and Norwich University Hospital, Norwich, Norfolk, UK
  1. Correspondence to Dr Christopher Atkins; c.atkins{at}uea.ac.uk

Abstract

Introduction Fatigue is a frequent and troublesome manifestation of chronic sarcoidosis. This symptom can be debilitating and difficult to treat, with poor response to the treatment. Symptomatic management with neurostimulants, such as methylphenidate, is a possible treatment option. The use of such treatment strategies is not without precedent and has been trialled in cancer-related fatigue. Their use in sarcoidosis requires further evaluation before it can be recommended for clinical practice.

Methods and analysis The Fatigue and Sarcoidosis—Treatment with Methylphenidate study is a randomised, controlled, parallel-arm and feasibility trial of methylphenidate for the treatment of sarcoidosis-associated fatigue. Patients are eligible if they have a diagnosis of sarcoidosis, significant fatigue (measured using the Fatigue Assessment Scale) and have stable disease. Up to 30 participants will be randomly assigned to either methylphenidate (20 mg two times per day) or identical placebo in a 3:2 ratio for 24 weeks. The primary objective is to collect data determining the feasibility of a future study powered to determine the clinical efficacy of methylphenidate for sarcoidosis-associated fatigue. The trial is presently open and will continue until July 2018.

Ethics and dissemination Ethical approval for the study was granted by the Cambridge Central Research Ethics Committee on 21 June 2016 (reference 16/EE/0087) and was approved and sponsored by the Norfolk and Norwich University Hospital (reference 190280). Clinical Trial Authorisation (EudraCT number 2016-000342-60) from the Medicines and Healthcare products Regulatory Agency (MHRA) was granted on 19 April 2016. Results will be presented at relevant conferences and submitted to appropriate journals following trial closure and analysis.

Trial registration number NCT02643732; Pre-results.

  • Interstitial Lung Disease
  • Sarcoidosis
  • Fatigue

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors CA, RF, AS, ABC, APJ and AMW: all made substantial contributions to the conception and design of the study. CA: wrote the manuscript drafts. AMW: made significant revisions to the manuscript. All authors read, amended and approved the final manuscript.

  • Funding This work is an independent research supported by the National Institute of Health Research (NIHR Doctoral Research Fellowship, Dr Chris Atkins, DRF-2015-08-190).

  • Disclaimer The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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