Negative results of the TRIUMPHANT-MS trial for treatment of fatigue in multiple sclerosis.
June Halper, MSN, MSCN: I know when I was logging on to ACTRIMS-ECTRIMS most recently that virtual 2020, there were a couple of studies. One was called TRIUMPHANT-MS trial of methylphenidate, modafinil, and amantadine. I remember Dr. Anne Cross, Lauren Krupp and I, did a study many, many years ago. Can you comment on that? It was kind of interesting.
Patricia K. Coyle, MD: TRIUMPHANT was a PCORI-funded study run at Johns Hopkins principally, and the goal was to test three of the top agents that are used to treat fatigue against placebo. And they entered 141 MS [multiple sclerosis] patients and they really did rolling crossover studies where for four weeks they would be on placebo or one of the three agents that you had mentioned with two week washouts. They did this study because the observation had been that the data, the clinical data supporting drugs helping fatigue is really weak. They wanted to take out these three principle agents and formally test them. They used a patient-reported outcome called the Modified Fatigue Impact Scale or MFIS as the outcome. None of these three top treatments for fatigue showed any significant impact on fatigue compared to placebo. It was a bust.
June Halper, MSN, MSCN: Oh wow.
Patricia K. Coyle, MD: They failed to show benefit for any of the three drugs. Now, of course, they argued, well, it’s only 141 patients. They did a post hoc analysis and those that had increased daytime sleepiness did show a response to methylphenidate and modafinil. But that’s a post hoc analysis. You can’t count it. It just emphasizes that we use drugs to treat fatigue, it’s only one of a systematic multicentric approach. And I wouldn't be so encouraging about it. I tell my patients there’s a 50% chance, but one on one somebody might really get a benefit from treatment with a drug, medication, but there are other ways to treat fatigue as well.
June Halper, MSN, MSCN: I remember when we did the study, God, it’s got to be in the midle 80s with Lauren Krupp, and we did it at Holy Name, we had the same result. It was really nothing outstanding.
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