MS: 3 commonly used drugs fail to alleviate fatigue

  • Lancet Neurol
  • 23.11.2020

  • von Susan London
  • Clinical Essentials
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Takeaway

  • None of the 3 medications commonly used to treat fatigue in patients with multiple sclerosis (MS) were significantly more efficacious than placebo.

Why this matters

Key results

  • Estimated mean Modified Fatigue Impact Scale total score:
    • 51.3 at baseline,
    • 40.6 with placebo,
    • 41.3 with amantadine,
    • 39.0 with modafinil, and
    • 38.6 with methylphenidate.
  • No significant difference for overall medication effect (P=.20).
  • Similar results for:
    • QoL in Neurological Disorders fatigue T score (P=.42).
    • Epworth Sleepiness Scale score (P=.071).
  • Adverse event rates:
    • 31% with placebo,
    • 39% with amantadine,
    • 40% with modafinil, and
    • 40% with methylphenidate.
  • 3 serious adverse events:
    • Pulmonary embolism and myocarditis on amantadine.
    • MS exacerbation requiring hospitalization on modafinil.

Study design

  • US phase 3, randomized controlled crossover trial (TRIUMPHANT-MS).
  • 3 medications vs placebo in 141 adult patients with MS and fatigue.
  • Randomization: 4 sequences of medication administration.
  • Main outcome: Modified Fatigue Impact Scale score at highest tolerated dose (week 5) of each treatment period.
  • Funding: Patient-Centered Outcomes Research Institute.

Limitations

  • Unknown generalizability.
  • Each treatment period was short (6 weeks).
  • Adherence was not monitored.
  • Limited power for subgroup analyses.