Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial

Contemporary Clinical Trials - Tập 64 - Trang 67-76 - 2018
Bardia Nourbakhsh1, Nisha Revirajan2, Emmanuelle Waubant2
1Department of Neurology, Johns Hopkins University, Baltimore, MD USA
2Department of Neurology, University of California, San Francisco, San Francisco, CA, USA

Tài liệu tham khảo

Frohman, 2006, Multiple sclerosis—the plaque and its pathogenesis, N. Engl. J. Med., 354, 942, 10.1056/NEJMra052130 Krupp, 2006, Fatigue is intrinsic to multiple sclerosis (MS) and is the most commonly reported symptom of the disease, Mult. Scler. Houndmills Basingstoke Engl., 12, 367, 10.1191/135248506ms1373ed Lerdal, 2007, A prospective study of patterns of fatigue in multiple sclerosis, Eur. J. Neurol., 14, 1338, 10.1111/j.1468-1331.2007.01974.x Janardhan, 2002, Quality of life in patients with multiple sclerosis: the impact of fatigue and depression, J. Neurol. Sci., 205, 51, 10.1016/S0022-510X(02)00312-X Blaney, 2009, The impact of fatigue on communication in multiple sclerosis. The insider's perspective, Disabil. Rehabil., 31, 170, 10.1080/09638280701869629 Smith, 2005, Factors related to employment status changes in individuals with multiple sclerosis, Mult. Scler. Houndmills Basingstoke Engl., 11, 602, 10.1191/1352458505ms1204oa Foley, 2009, Redefining functionality and treatment efficacy in multiple sclerosis, Neurology, 72, S1, 10.1212/WNL.0b013e3181a99bc2 Induruwa, 2012, Fatigue in multiple sclerosis - a brief review, J. Neurol. Sci., 323, 9, 10.1016/j.jns.2012.08.007 Braley, 2010, Fatigue in multiple sclerosis: mechanisms, evaluation, and treatment, Sleep, 33, 1061, 10.1093/sleep/33.8.1061 Toosy, 2014, Symptomatic treatment and management of multiple sclerosis, Handb. Clin. Neurol., 122, 513, 10.1016/B978-0-444-52001-2.00023-6 Pucci, 2007, Amantadine for fatigue in multiple sclerosis, Cochrane Database Syst. Rev., CD002818 Tejani, 2012, Carnitine for fatigue in multiple sclerosis, Cochrane Database Syst. Rev., 5, CD007280 Ledinek, 2013, Evaluating the effects of amantadin, modafinil and acetyl-L-carnitine on fatigue in multiple sclerosis—result of a pilot randomized, blind study, Clin. Neurol. Neurosurg., 115, S86, 10.1016/j.clineuro.2013.09.029 Shaygannejad, 2012, Comparison of the effect of aspirin and amantadine for the treatment of fatigue in multiple sclerosis: a randomized, blinded, crossover study, Neurol. Res., 34, 854, 10.1179/1743132812Y.0000000081 Tomassini, 2004, Comparison of the effects of acetyl l-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial, J. Neurol. Sci., 218, 103, 10.1016/j.jns.2003.11.005 Polman, 2011, Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria, Ann. Neurol., 69, 292, 10.1002/ana.22366 Feys, 2012, Effect of time of day on walking capacity and self-reported fatigue in persons with multiple sclerosis: a multi-center trial, Mult. Scler. Houndmills Basingstoke Engl., 18, 351, 10.1177/1352458511419881 Thorpe, 2009, A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers, CMAJ Can. Med. Assoc. J., 180, E47, 10.1503/cmaj.090523 Hayden, 1996, Combination antiviral therapy for respiratory virus infections, Antivir. Res., 29, 45, 10.1016/0166-3542(95)00914-0 Yacoubian, 2009, Targets for neuroprotection in Parkinson's disease, Biochim. Biophys. Acta BBA-Mol. Basis Dis., 1792, 676, 10.1016/j.bbadis.2008.09.009 Geisler, 1996, The effects of amantadine and pemoline on cognitive functioning in multiple sclerosis, Arch. Neurol., 53, 185, 10.1001/archneur.1996.00550020101021 Krupp, 1995, Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo, Neurology, 45, 1956, 10.1212/WNL.45.11.1956 Stein, 1995, A double-blind, placebo-controlled trial of amantadine for the treatment of fatigue in patients with the post-polio syndrome, Ann. N. Y. Acad. Sci., 753, 296, 10.1111/j.1749-6632.1995.tb27555.x Rosenberg, 1988, Amantadine, fatigue, and multiple sclerosis, Arch. Neurol., 45, 1104, 10.1001/archneur.1988.00520340058012 Lange, 2009, Modafinil effects in multiple sclerosis patients with fatigue, J. Neurol., 256, 645, 10.1007/s00415-009-0152-7 Kumar, 2008, Approved and investigational uses of modafinil: an evidence-based review, Drugs, 68, 1803, 10.2165/00003495-200868130-00003 Hadjimichael, 2008, Fatigue characteristics in multiple sclerosis: the North American Research Committee on Multiple Sclerosis (NARCOMS) survey, Health Qual. Life Outcomes, 6, 100, 10.1186/1477-7525-6-100 Stankoff, 2005, Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study, Neurology, 64, 1139, 10.1212/01.WNL.0000158272.27070.6A Sheng, 2013, Efficacy of modafinil on fatigue and excessive daytime sleepiness associated with neurological disorders: a systematic review and meta-analysis, PLoS One, 8, 10.1371/journal.pone.0081802 Mitler, 2000, Long-term efficacy and safety of modafinil (PROVIGIL((R))) for the treatment of excessive daytime sleepiness associated with narcolepsy, Sleep Med., 1, 231, 10.1016/S1389-9457(00)00031-9 Mitler, 1994, Narcolepsy and its treatment with stimulants. ASDA standards of practice, Sleep, 17, 352, 10.1093/sleep/17.suppl_8.S103 Bassetti, 1996, Narcolepsy, Neurol. Clin., 14, 545, 10.1016/S0733-8619(05)70273-5 Breitbart, 2001, 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., 161, 411, 10.1001/archinte.161.3.411 Escalante, 2014, A randomized, double-blind, 2-period, placebo-controlled crossover trial of a sustained-release methylphenidate in the treatment of fatigue in cancer patients, Cancer J. Sudbury Mass, 20, 8, 10.1097/PPO.0000000000000018 Kerr, 2012, Effects of methylphenidate on fatigue and depression: a randomized, double-blind, placebo-controlled trial, J. Pain Symptom Manag., 43, 68, 10.1016/j.jpainsymman.2011.03.026 Cueva, 2012, Methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel: results of a pilot study, Investig. New Drugs, 30, 688, 10.1007/s10637-010-9539-7 Krupp, 2001, Fatigue in multiple sclerosis, Curr. Neurol. Neurosci. Rep., 1, 294, 10.1007/s11910-001-0033-7 Weinshenker, 1992, A double-blind, randomized, crossover trial of pemoline in fatigue associated with multiple sclerosis, Neurology, 42, 1468, 10.1212/WNL.42.8.1468 Téllez, 2005, Does the Modified Fatigue Impact Scale offer a more comprehensive assessment of fatigue in MS?, Mult. Scler. Houndmills Basingstoke Engl., 11, 198, 10.1191/1352458505ms1148oa Kos, 2005, Evaluation of the Modified Fatigue Impact Scale in four different European countries, Mult. Scler. Houndmills Basingstoke Engl., 11, 76, 10.1191/1352458505ms1117oa Gillson, 2002, A double-blind pilot study of the effect of Prokarin on fatigue in multiple sclerosis, Mult. Scler. Houndmills Basingstoke Engl., 8, 30, 10.1177/135245850200800107 Rammohan, 2002, Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study, J. Neurol. Neurosurg. Psychiatry, 72, 179, 10.1136/jnnp.72.2.179 Schwid, 2003, A randomized controlled study of the acute and chronic effects of cooling therapy for MS, Neurology, 60, 1955, 10.1212/01.WNL.0000070183.30517.2F Cella, 2012, Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology, Neurology, 78, 1860, 10.1212/WNL.0b013e318258f744 Gershon, 2012, Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing, Qual. Life Res. Int. J. Qual. Life Asp. Treat. Care Rehab., 21, 475, 10.1007/s11136-011-9958-8 Cook, 2015, Creating meaningful cut-scores for Neuro-QOL measures of fatigue, physical functioning, and sleep disturbance using standard setting with patients and providers, Qual. Life Res. Int. J. Qual. Life Asp. Treat. Care Rehab., 24, 575, 10.1007/s11136-014-0790-9 Miller, 2015, Validating Neuro-QoL short forms and targeted scales with people who have multiple sclerosis Flachenecker, 2002, Fatigue in multiple sclerosis: a comparison of different rating scales and correlation to clinical parameters, Mult. Scler., 8, 523, 10.1191/1352458502ms839oa Gilron, 2005, Morphine, gabapentin, or their combination for neuropathic pain, N. Engl. J. Med., 352, 1324, 10.1056/NEJMoa042580 Rubin, 1996, Multiple imputation after 18+ years, J. Am. Stat. Assoc., 91, 473, 10.1080/01621459.1996.10476908 Ontaneda, 2015, Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives, Lancet Neurol., 14, 208, 10.1016/S1474-4422(14)70264-9 Weiland, 2015, Clinically significant fatigue: prevalence and associated factors in an international sample of adults with multiple sclerosis recruited via the internet, PLoS One, 10, e0115541, 10.1371/journal.pone.0115541 Taylor, 2014, Lifestyle factors, demographics and medications associated with depression risk in an international sample of people with multiple sclerosis, BMC Psychiatry, 14, 327, 10.1186/s12888-014-0327-3 Watson, 2014, Validation of mood measures for people with multiple sclerosis, Int. J. MS Care, 16, 105, 10.7224/1537-2073.2013-013 Metz, 2004, The effect of immunomodulatory treatment on multiple sclerosis fatigue, J. Neurol. Neurosurg. Psychiatry, 75, 1045, 10.1136/jnnp.2002.007724 Putzki, 2008, Prevalence and severity of multiple-sclerosis-associated fatigue in treated and untreated patients, Eur. Neurol., 59, 136, 10.1159/000111876 Putzki, 2009, Multiple sclerosis associated fatigue during natalizumab treatment, J. Neurol. Sci., 285, 109, 10.1016/j.jns.2009.06.004 Wilken, 2013, Changes in fatigue and cognition in patients with relapsing forms of multiple sclerosis treated with Natalizumab: The ENER-G study, Int. J. MS Care, 15, 120, 10.7224/1537-2073.2012-043 Koch, 2009, Fatigue, depression and disability accumulation in multiple sclerosis: a cross-sectional study, Eur. J. Neurol., 16, 348, 10.1111/j.1468-1331.2008.02432.x Pittion-Vouyovitch, 2006, Fatigue in multiple sclerosis is related to disability, depression and quality of life, J. Neurol. Sci., 243, 39, 10.1016/j.jns.2005.11.025 Kurtzke, 1983, Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS), Neurology, 33, 1444, 10.1212/WNL.33.11.1444 Larson, 2013, Psychometric properties of the Modified Fatigue Impact Scale, Int. J. MS Care, 15, 15, 10.7224/1537-2073.2012-019 Kos, 2007, Multidisciplinary fatigue management programme in multiple sclerosis: a randomized clinical trial, Mult. Scler., 13, 996, 10.1177/1352458507078392 Waubant, 2014, A randomized controlled phase II trial of riluzole in early multiple sclerosis, Ann. Clin. Transl. Neurol., 1, 340, 10.1002/acn3.60