Phase 3 randomized, controlled trial of methylphenidate, modafinil and amantadine for MS fatigue (TRIUMPHANT-MS): Baseline data
ECTRIMS Online Library. Nourbakhsh B. 09/13/19; 278624; P1424
Bardia Nourbakhsh
Bardia Nourbakhsh
Contributions
Abstract

Abstract: P1424

Type: Poster Sessions

Abstract Category: Therapy - Symptomatic treatment

B. Nourbakhsh1, N. Revirajan2, B. Morris1, J. Creasman3, M. Manguinao2, K. Krysko2, A. Rutatangwa2, S. Aljarallah1, E. Waubant2

1Johns Hopkins University | Neurology, Johns Hopkins University, Baltimore, MD, 2UCSF Weill Institute for Neurosciences, University of California San Francisco, 3UCSF, San Francisco, CA, United States

Background: The evidence supporting the use of various medications to treat fatigue, the most common MS symptom, is scarce. This pragmatic clinical trial is conducted to compare the efficacy and tolerability of commonly used medications for treatment of MS-related fatigue.
Methods: TRIUMPHANT-MS is a randomized, double-blind, crossover, four-sequence, four-period multicenter trial of methylphenidate, modafinil and amantadine versus placebo in patients with MS reporting chronic fatigue. Adult patients with EDSS ≤ 7.0 and Modified Fatigue Impact Scale (MFIS) score >33 were eligible to participate. Participants were randomized to one of four medication sequences. Each sequence is comprised of six-week medication periods for each study medication and placebo (total of four periods) in various orders. Primary outcome (MFIS) and secondary and exploratory outcomes are assessed in each medication period while the patient is receiving the highest dose (amantadine and modafinil up to 200 mg daily and methylphenidate up to 20 mg daily). Medication periods are separated by a two-week washout.
Results: 168 patients with MS were screened, of whom 141 were randomized (77.3% female, mean age 46 years +/- 11.4). 75% of participants had relapsing-remitting MS, and the rest progressive forms of MS. At screening, median EDSS was 3 (range= 0 -7) and mean MFIS score 54 +/- 11.5. Screening MFIS scores were weakly correlated with sleepiness (Spearman's rho=0.21, p=0.009) and moderately with depressive symptoms (rho=0.49, p< 0.0001). Screening MFIS score was not correlated with sex, type of MS, disease duration and EDSS score. The last subject is projected to complete the study in November 2019.
Conclusion: TRIUMPHANT-MS is a pragmatic randomized clinical trial designed to assess efficacy, relative effectiveness and tolerability of the most commonly used medications for MS-related fatigue in clinical practice.
Disclosure:
Research reported in this abstract was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (MS-1511-33689).
Bardia Nourbakhsh: Received consulting fees from Jazz Pharmaceutical. Research support from PCORI, NMSS, American Brain Foundation, BiogenReceived consulting fees from Jazz Pharmaceutical. Research support from PCORI, NMSS, American Brain Foundation, Biogen
Nisha Revirajan: nothing to disclose
Bridget Morris: nothing to disclose
Jennifer Creasman: nothing to disclose
Michael Manguinao: nothing to disclose
Kristen Krysko: is supported by the Sylvia Lawry award from the National Multiple Sclerosis Society, and a Biogen MS fellowship grant
Alice Rutatangwa: nothing to disclose
Salman Aljarallah: nothing to disclose
Emmanuelle Wauban: is site PI for ongoing trials with Genentech and Biogen. She has research funding from NIH, PCORI, NMSS, and Race to Erase MS. She has received honoraria for lectures for Medscape, The Corpus and AAN, and for consulting work from Jazz Pharmaceuticals, Emerald and DBV. She is co-chief editor for MSARD.

Abstract: P1424

Type: Poster Sessions

Abstract Category: Therapy - Symptomatic treatment

B. Nourbakhsh1, N. Revirajan2, B. Morris1, J. Creasman3, M. Manguinao2, K. Krysko2, A. Rutatangwa2, S. Aljarallah1, E. Waubant2

1Johns Hopkins University | Neurology, Johns Hopkins University, Baltimore, MD, 2UCSF Weill Institute for Neurosciences, University of California San Francisco, 3UCSF, San Francisco, CA, United States

Background: The evidence supporting the use of various medications to treat fatigue, the most common MS symptom, is scarce. This pragmatic clinical trial is conducted to compare the efficacy and tolerability of commonly used medications for treatment of MS-related fatigue.
Methods: TRIUMPHANT-MS is a randomized, double-blind, crossover, four-sequence, four-period multicenter trial of methylphenidate, modafinil and amantadine versus placebo in patients with MS reporting chronic fatigue. Adult patients with EDSS ≤ 7.0 and Modified Fatigue Impact Scale (MFIS) score >33 were eligible to participate. Participants were randomized to one of four medication sequences. Each sequence is comprised of six-week medication periods for each study medication and placebo (total of four periods) in various orders. Primary outcome (MFIS) and secondary and exploratory outcomes are assessed in each medication period while the patient is receiving the highest dose (amantadine and modafinil up to 200 mg daily and methylphenidate up to 20 mg daily). Medication periods are separated by a two-week washout.
Results: 168 patients with MS were screened, of whom 141 were randomized (77.3% female, mean age 46 years +/- 11.4). 75% of participants had relapsing-remitting MS, and the rest progressive forms of MS. At screening, median EDSS was 3 (range= 0 -7) and mean MFIS score 54 +/- 11.5. Screening MFIS scores were weakly correlated with sleepiness (Spearman's rho=0.21, p=0.009) and moderately with depressive symptoms (rho=0.49, p< 0.0001). Screening MFIS score was not correlated with sex, type of MS, disease duration and EDSS score. The last subject is projected to complete the study in November 2019.
Conclusion: TRIUMPHANT-MS is a pragmatic randomized clinical trial designed to assess efficacy, relative effectiveness and tolerability of the most commonly used medications for MS-related fatigue in clinical practice.
Disclosure:
Research reported in this abstract was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (MS-1511-33689).
Bardia Nourbakhsh: Received consulting fees from Jazz Pharmaceutical. Research support from PCORI, NMSS, American Brain Foundation, BiogenReceived consulting fees from Jazz Pharmaceutical. Research support from PCORI, NMSS, American Brain Foundation, Biogen
Nisha Revirajan: nothing to disclose
Bridget Morris: nothing to disclose
Jennifer Creasman: nothing to disclose
Michael Manguinao: nothing to disclose
Kristen Krysko: is supported by the Sylvia Lawry award from the National Multiple Sclerosis Society, and a Biogen MS fellowship grant
Alice Rutatangwa: nothing to disclose
Salman Aljarallah: nothing to disclose
Emmanuelle Wauban: is site PI for ongoing trials with Genentech and Biogen. She has research funding from NIH, PCORI, NMSS, and Race to Erase MS. She has received honoraria for lectures for Medscape, The Corpus and AAN, and for consulting work from Jazz Pharmaceuticals, Emerald and DBV. She is co-chief editor for MSARD.

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