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Methylphenidate, modafinil, and amantadine are commonly
prescribed medications for alleviating fatigue in multiple
sclerosis (MS); however, the evidence supporting their efficacy
is sparse and conflicting. Our goal was to compare the efficacy
of these three medications against each other and placebo in
patients with MS-related fatigue. BN has received funding from
the National MS Society (NMSS), PCORI, and Genentech and personal
fees from Jazz Pharmaceutical. CM has received funding from
PCORI. EW has received personal fee from Jazz Pharmaceutical,
Emerald, and DBV. KK has received funding from PCORI, NMSS and
Biogen. EM has received research support from Teva, grants from
Sun Pharma, Sanofi Genzyme, Biogen, and personal fees from
UpToDate. NR, BM, CC, JC, MM, AR, CA, SA, CJ declare no competing
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justo. One hundred and seventeen (92) participants tolerated the
maximum dose of amantadine (200 mg daily), while 108 (86) and 112
(87) participants tolerated the maximum doses of modafinil (200
mg daily) and methylphenidate (20 mg daily), respectively. One
hundred and seventeen (94) participants tolerated the maximum
number of placebo capsules. Seven (6) participants discontinued
amantadine before the end of the medication period, and 120 (95)
tolerated at least half of the maximum dose. Ten (8) and seven
(5) participants stopped modafinil and methylphenidate before the
end of the medication period, respectively. At least half of the
maximum dose was tolerated by 115 (92) participants for modafinil
and 118 (92) for methylphenidate.
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In conclusion, amantadine, modafinil, and methylphenidate were not superior to placebo in improving MS fatigue assessed by validated outcome measures and resulted in more frequent adverse events. The widespread use of these medications for MS fatigue in clinical practice is probably mostly related to a placebo effect reported by the patients. Based on our results, physicians should reduce the use of these medications for the treatment of MS-related fatigue. Our post hoc analysis suggested that, when compared with placebo, modafinil and methylphenidate might result in small improvements in fatigue in a subset of patients with excessive daytime sleepiness. Further research is needed to confirm this result and to elucidate the pathophysiology of fatigue in MS and its contributing factors, improve outcome measures, and develop effective interventions. The trial was exempt from the requirements for an Investigational New Drug application with the FDA. The institutional review boards approved the study at Johns Hopkins University (JHU) and the University of California, San Francisco (UCSF) (approval number at JHU: IRB00119702, approval number at UCSF: 1722584). All participants provided written informed consent. We evaluated the trial post hoc as a parallel-group design by restricting the primary efficacy outcome analysis to the first medication period.
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The estimated mean values for the MFIS total score (95 CI) at the highest or maximum tolerated dose (week 5) in the first medication period were as follows: 39. 8 (35. 1 to 44. 5) with placebo, 43. 4 (38. 6 to 48. 2) with amantadine, 37. 2 (32. 4 to 42. 0) with modafinil, and 39. 8 (35. 3 to 44. 4) with methylphenidate. There was no statistically significant difference among study drugs on the estimated mean values of MFIS total score in the first medication period (p-value for the overall medication effect: ). Methylphenidate had never been tested in a randomized clinical trial for MS-related fatigue; however, amantadine and modafinil were tested in numerous randomized trials for this clinical ,22 The results of these trials were mixed: some reported amantadine and modafinil were effective for MS-related fatigue, while some did not report a 20 The efficacy dataset included all participants who had the primary outcome measured in week 5 of at least one treatment period. Following the intention-to-treat (ITT) principle, participants were analyzed according to the randomized sequence assignment. The safety dataset included all patients who received at least one dose of any study medication. Safety was analyzed according to the actual treatment received.
Fatigue (as defined as a subjective lack of physical or mental energy perceived by the individual with usual activities) is distinct from excessive daytime sleepiness. Sleepiness, defined as difficulty to stay awake and alert during the day, is less common and less severe than fatigue in patients with MS. A systematic review reported a moderate association between the ESS score and various fatigue rating scales in There was a weak association between the MFIS total score and ESS score at the time of screening in our study. The effect of medications on fatigue may also be modified by the presence of daytime sleepiness. In our post hoc analysis, modafinil and methylphenidate improved fatigue impact more than placebo in patients with excessive daytime sleepiness. These improvements were marginally clinically significant (more than four points on MFIS total score). This observation is in line with another clinical trial of modafinil, which reported an improvement in the physical subscale of the MFIS score, only in patients with excessive daytime These results suggest that excessive daytime sleepiness or its underlying pathophysiology may contribute to fatigue impact in a subset of patients with MS. In those patients, wake-promoting agents, such as modafinil and methylphenidate, may have a marginal, but clinically significant effect in improving fatigue. These results were obtained from post hoc analyses and should be interpreted with caution. 5º - Na hipótese do 3º, se o criminoso é primário, pode o juiz, tendo em consideração as circunstâncias, deixar de aplicar a pena. Na receptação dolosa aplica-se o disposto no 2º do CP, art. 155. Amantadine, modafinil, and amphetamine-like stimulants (such as methylphenidate, amphetamine/dextroamphetamine, and lisdexamfetamine) are among the most commonly used medications to treat MS ,11 Both amantadine1215 and modafinil14,1620 have been tested in several clinical trials for MS fatigue. Still, the methodological shortcomings and conflicting results have prevented any definite conclusion regarding their ,22 Aside from three clinical trials of pemoline15,23,24, a stimulant that is no longer available in the United States, psychostimulants have not been tested in randomized controlled trials for MS fatigue. Methylphenidate has been tested in several randomized controlled trials of fatigue in conditions other than MS25,26 that have yielded conflicting results. Most of these medications are wake-promoting agents; however, MS fatigue is not equivalent to excessive daytime sleepiness. Despite the widespread use of amantadine, modafinil, and amphetamine-like stimulants, it remains unclear if any improves MS-related fatigue better than placebo, and if so, which one is most effective, better tolerated, and has the fewest side effects. It is also unknown whether comorbid conditions such as depression or potentially relevant factors, such as MS subtype, the severity of the physical disability, or the use of immune-based disease-modifying therapies alter the effect of these medications on MS fatigue. In a pragmatic randomized trial, we compared the efficacy, safety, and tolerability of amantadine, modafinil, methylphenidate, and placebo in patients with MS-related fatigue. No litoral, o verão oferece inúmeras possibilidades de atividades para relaxar em família ou entre amigos. Entre praias e banhos, porque não tentar a pesca? Uma pescaria é uma excelente oportunidade para miúdos e graúdos descobrirem ou redescobrirem o fascinante mundo marinho.