Efficacy and safety of modafinil (Provigil)
for the treatment of fatigue in multiple sclerosis.
Rammohan KW, Rosenberg JH, Lynn DJ,
Blumenfeld AM, Pollak CP, Nagaraja HN
Department of Neurology
Ohio State University
449 Means Hall, 1654 Upham Drive
Columbus, Ohio 43210
rammohan.2@osu.edu
J Neurol Neurosurg Psychiatry. 2002 Feb;72(2):179-83
ABSTRACT
OBJECTIVE: To assess the efficacy
and safety of modafinil for the treatment of fatigue in multiple sclerosis
(MS).
METHODS: Patients aged 18-65 years
with a diagnosis of MS, a stable disability level < or =6 on the Kurtzke
extended disability status scale (EDSS), and a mean score >4 on the fatigue
severity scale (FSS) were eligible for the 9 week, single blind, phase 2, two
centre study. Exclusion criteria included a diagnosis of narcolepsy, sleep
apnoea, or clinically significant major systemic disease and recent use of
medications affecting fatigue. All patients, who remained blinded for the
treatment regimen, received placebo during weeks 1-2, 200 mg/day modafinil
during weeks 3-4, 400 mg/day modafinil during weeks 5-6, and placebo during
weeks 7-9. Safety was evaluated by unblinded investigators. Efficacy was
evaluated by self rating scales, using the FSS, the modified fatigue impact
scale (MFIS), a visual analogue scale for fatigue (VAS-F), and the Epworth
sleepiness scale (ESS). Adverse events were recorded.
RESULTS: Seventy two patients (MS
type: 74% relapsing-remitting; 7% primary progressive; 19% secondary
progressive) received treatment. After treatment with 200 mg/day modafinil for
2 weeks, a significant improvement in fatigue versus placebo run in was
demonstrated. Mean scores after treatment with 200 mg/day modafinil were: FSS,
4.7 versus 5.5 for placebo (p<0.001); MFIS, 37.7 versus 44.7 (p<0.001);
and VAS-F, 5.4 versus 4.5 (p=0.003). Fatigue scores for 400 mg/day modafinil
were not significantly improved versus placebo run in. Mean ESS scores were
significantly improved (p<0.001) with 200 mg/day modafinil (7.2) and 400
mg/day (7.0) versus the score at baseline (9.5). Serious adverse events were
not found at either dose. The most common adverse events were headache,
nausea, and aesthenia. Sixty five patients (90%) completed the study.
CONCLUSIONS: These data suggest
that 200 mg/day modafinil significantly improves fatigue and is well tolerated
in patients with MS.
|
Home | to
Order |
1. Modafinil augmentation
of antidepressant treatment
2. Modafinil children
with attention-deficit/hyperactivity disorder
3. Modafinil in
fibromyalgia treatment
4. Modafinil
efficacy in narcolepsy
5. Modafinil narcolepsy:
symptoms and management
6. Modafinil successful
treatment of hypersomnia & narcolepsy
7. Modafinil
drug of choice for narcolepsy
8. Modafinil
in the treatment of
narcolepsy
9. Modafinil
effect on narcolepsy
10. Modafinil
a narcolepsy study
11. Modafinil
switching from narcolepsy drugs to modafinil
12. Modafinil
and naps as counter measures in sleep deprivation
13. Modafinil
as a treatment for excessive daytime sleepiness
14. Modafinil
use in a sleep deprivation experiment
15. Modafinil excessive sleepiness in Parkinson's disease
16. Modafinil the
unique properties of a new stimulant
17. Modafinil for
sustaining the alertness of helicopter pilots
18. Modafinil dosage
and safety
19. Modafinil
treatment of alcoholic organic brain syndrome
20. Modafinil
effect on melatonin, cortisol, and growth hormone
21. Modafinil
in obstructive sleep apnea-hypopnea syndrome
22. Modafinil
vs dextroamphetamine in treatment of adult ADHD
23. Modafinil
dopaminergic transmission mediates CNS stimulants
24. Modafinil
for daytime sleepiness in sleep apnea
25. Modafinil
treatment of residual excessive daytime sleepiness
26. Modafinil
amplification of cortical serotonin release
27. Modafinil for the treatment of
multiple sclerosis
