Fatigue in Sarcoidosis - Treatment With Methylphenidate

Summary

This is a small randomised-controlled trial (RCT) using methylphenidate as a treatment for clinically-significant fatigue in sarcoidosis patients with stable disease. The primary outcomes are feasibility, aimed at determining factors that will influence the design a future, larger RCT, which will be powered to look at clinical efficacy of the intervention.

Timeline

Start

2016-11

Primary completion

2018-05

Completion

2018-07

Publications

• Background Gribbin J, Hubbard RB, Le Jeune I, Smith CJ, West J, Tata LJ. Incidence and mortality of idiopathic pulmonary fibrosis and sarcoidosis in the UK. Thorax. 2006 Nov;61(11):980-5. doi: 10.1136/thx.2006.062836. Epub 2006 Jul 14.
• Background Iannuzzi MC, Rybicki BA, Teirstein AS. Sarcoidosis. N Engl J Med. 2007 Nov 22;357(21):2153-65. doi: 10.1056/NEJMra071714. No abstract available.
• Background Marcellis RG, Lenssen AF, Elfferich MD, De Vries J, Kassim S, Foerster K, Drent M. Exercise capacity, muscle strength and fatigue in sarcoidosis. Eur Respir J. 2011 Sep;38(3):628-34. doi: 10.1183/09031936.00117710. Epub 2011 Mar 24.
• Background James DG. Complications of sarcoidosis. Chronic fatigue syndrome. Sarcoidosis. 1993 Mar;10(1):1-3.
• Background Michielsen HJ, Drent M, Peros-Golubicic T, De Vries J. Fatigue is associated with quality of life in sarcoidosis patients. Chest. 2006 Oct;130(4):989-94. doi: 10.1378/chest.130.4.989.
• Background Turner GA, Lower EE, Corser BC, Gunther KL, Baughman RP. Sleep apnea in sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 1997 Mar;14(1):61-4.
• Background Drent M, Verbraecken J, van der Grinten C, Wouters E. Fatigue associated with obstructive sleep apnea in a patient with sarcoidosis. Respiration. 2000;67(3):337-40. doi: 10.1159/000029523.
• Background Bradley B, Branley HM, Egan JJ, Greaves MS, Hansell DM, Harrison NK, Hirani N, Hubbard R, Lake F, Millar AB, Wallace WA, Wells AU, Whyte MK, Wilsher ML; British Thoracic Society Interstitial Lung Disease Guideline Group, British Thoracic Society Standards of Care Committee; Thoracic Society of Australia; New Zealand Thoracic Society; Irish Thoracic Society. Interstitial lung disease guideline: the British Thoracic Society in collaboration with the Thoracic Society of Australia and New Zealand and the Irish Thoracic Society. Thorax. 2008 Sep;63 Suppl 5:v1-58. doi: 10.1136/thx.2008.101691. No abstract available.
• Background Costabel U, Hunninghake GW. ATS/ERS/WASOG statement on sarcoidosis. Sarcoidosis Statement Committee. American Thoracic Society. European Respiratory Society. World Association for Sarcoidosis and Other Granulomatous Disorders. Eur Respir J. 1999 Oct;14(4):735-7. doi: 10.1034/j.1399-3003.1999.14d02.x. No abstract available.
• Background Keating GM, Figgitt DP. Dexmethylphenidate. Drugs. 2002;62(13):1899-904; discussion 1905-8. doi: 10.2165/00003495-200262130-00009.
• Background Volkow ND, Fowler JS, Wang G, Ding Y, Gatley SJ. Mechanism of action of methylphenidate: insights from PET imaging studies. J Atten Disord. 2002;6 Suppl 1:S31-43. doi: 10.1177/070674370200601s05.
• Background Lower EE, Fleishman S, Cooper A, Zeldis J, Faleck H, Yu Z, Manning D. Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. J Pain Symptom Manage. 2009 Nov;38(5):650-62. doi: 10.1016/j.jpainsymman.2009.03.011.
• Background Minton O, Richardson A, Sharpe M, Hotopf M, Stone P. Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD006704. doi: 10.1002/14651858.CD006704.pub3.
• Background Breitbart W, Rosenfeld B, Kaim M, Funesti-Esch J. A randomized, double-blind, placebo-controlled trial of psychostimulants for the treatment of fatigue in ambulatory patients with human immunodeficiency virus disease. Arch Intern Med. 2001 Feb 12;161(3):411-20. doi: 10.1001/archinte.161.3.411.
• Background Butler JM Jr, Case LD, Atkins J, Frizzell B, Sanders G, Griffin P, Lesser G, McMullen K, McQuellon R, Naughton M, Rapp S, Stieber V, Shaw EG. A phase III, double-blind, placebo-controlled prospective randomized clinical trial of d-threo-methylphenidate HCl in brain tumor patients receiving radiation therapy. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1496-501. doi: 10.1016/j.ijrobp.2007.05.076. Epub 2007 Sep 14.
• Background Lower EE, Harman S, Baughman RP. Double-blind, randomized trial of dexmethylphenidate hydrochloride for the treatment of sarcoidosis-associated fatigue. Chest. 2008 May;133(5):1189-95. doi: 10.1378/chest.07-2952. Epub 2008 Feb 8.
• Background Holland AE, Dowman L, Fiore J Jr, Brazzale D, Hill CJ, McDonald CF. Cardiorespiratory responses to 6-minute walk test in interstitial lung disease: not always a submaximal test. BMC Pulm Med. 2014 Aug 11;14:136. doi: 10.1186/1471-2466-14-136.
• Background Korenromp IHE, Heijnen CJ, Vogels OJM, van den Bosch JMM, Grutters JC. Characterization of chronic fatigue in patients with sarcoidosis in clinical remission. Chest. 2011 Aug;140(2):441-447. doi: 10.1378/chest.10-2629. Epub 2011 Feb 17.
• Atkins C, Jones A, Clark AB, Stockl A, Fordham R, Wilson AM. Feasibility of investigating methylphenidate for the treatment of sarcoidosis-associated fatigue (the FaST-MP study): a double-blind, parallel-arm randomised feasibility trial. BMJ Open Respir Res. 2021 May;8(1):e000814. doi: 10.1136/bmjresp-2020-000814.
• Atkins C, Fordham R, Clark AB, Stockl A, Jones AP, Wilson AM. Feasibility study of a randomised controlled trial to investigate the treatment of sarcoidosis-associated fatigue with methylphenidate (FaST-MP): a study protocol. BMJ Open. 2017 Dec 4;7(12):e018532. doi: 10.1136/bmjopen-2017-018532.

Drugs

Indications