Provigil® Among Recommendations in Treatment
of MS Fatigue
A Working Group of neurologists has recommended
the wake-promoting agent Provigil® (generic name:
modafinil), as the first line of treatment for moderate
to severe MS fatigue. Provigil was initially approved
in the US in 1998 for the treatment of excessive
daytime sleepiness and narcolepsy.
The neurologists presented their conclusions at
a symposium of the annual meeting of the Consortium
of Multiple Sclerosis Centers (CMSC) in June 2002.
MS fatigue is reported by more than 95 percent of
people with MS, and is considered to be the worst
symptom in as much as 50 percent of individuals with
MS.
The recommendation is based on a study examining
the efficacy and safety of Provigil. Led by Kottil
W. Rammohan, MD, of Ohio State University, and Jay
H. Rosenberg, MD of Kaiser Permanente, the results
of this nine-week, two-center, phase II study were
recently reported in The Journal of Neurology, Neurosurgery,
and Psychiatry (2002, vol. 72, pp. 179-183).
During the single-blinded study, all 72 individuals
with MS were given a placebo, 200 mg/day of Provigil,
or 400 mg/day of Provigil, in two-week increments.
The data suggested that 200 mg/day of Provigil significantly
improves MS fatigue and is well tolerated. The 400-mg/day
dose did not differ in efficacy from the placebo
in certain outcome measures. No drug interactions
were observed with Provigil in conjunction with long-term
immunologic therapies, and no serious adverse events
occurred at either dose. Side effects were usually
mild and included headache and sleeplessness in some
patients. The Working Group recommended starting
Provigil at a lower dose and increasing the dose
to 200 mg/day.
Additionally, the Working Group found self-assessment
scales to be the most efficient means of measuring
MS fatigue, and also recommended amantadine (Symmetrel®)
as a first-line treatment for mild MS fatigue (although
this is shown to be effective in only 20 to 40 percent
of patients). Pemoline (Cylert®) is no longer
recommended as a first-line option due to safety
concerns and limited effectiveness. Other agents,
such as aminopyridines and SSRIs (selective serotonin
reuptake inhibitors such as Prozac®), have yet
to be approved for treating MS fatigue, although
they may be useful for some individuals.
More studies are needed to determine the long-term
safety and efficacy of Provigil. The FDA has yet
to approve MS fatigue as an indication for prescribing
Provigil, and more research into the cause of MS
fatigue and its relationship to other MS symptoms
is necessary. Fatigue therapies must be individualized,
as responses to any therapy can vary from one person
to another.
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