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