provigil an article

[Guest guest]

I found this fascinating- perhaps eventually an answer for the crushing fatigue

of FMS or CFIDS?

Provigil Reduces Fatigue In MS And Other Disorders

SAN FRANCISCO, CA -- January 14, 2000 -- Cephalon, Inc. president and chief

executive officer, Baldino, Jr.,

Ph.D., reported positive new findings from recently completed clinical studies

with the company's flagship product, Provigil®

(modafinil) Tablets [C-IV]. The company currently markets Provigil in several

countries, including the United States, for the

treatment of excessive daytime sleepiness (EDS) associated with narcolepsy.

In remarks delivered to investors attending Hambrecht & Quist's 18th Annual

Healthcare Conference in San Francisco, Dr.

Baldino reported that data from a 72-patient, placebo-controlled multiple

sclerosis (MS) fatigue study showed that 200 mg of

Provigil reduced fatigue in patients. As measured by several validated fatigue

rating scales, this reduction was statistically

significant. Approximately 80 percent of the 250,000-350,000 people with MS

experience fatigue; in many patients, fatigue

may be the most prominent and disabling symptom. Cephalon may conduct additional

studies of Provigil in patients with MS

fatigue later this year.

In another trial, data from a placebo-controlled simulated shift work study in

16 individuals indicated that 200 mg of Provigil

promoted alertness and improved performance as measured by several validated

scales. These data were statistically

significant. Because shift workers typically work during the night, they often

experience a disruption in their sleep/wake cycle,

which can lead to impaired performance. Sleep/wake cycle disruptions interfere

with the body's internal biological clock that

regulates several important cellular processes, including sleep. According to

the U.S Department of Labor, approximately

fourteen million Americans are shift workers.

In these studies, the most frequently reported side effects potentially

attributable to the drug were nervousness, nausea, dry

mouth, headache, and diarrhea, which were consistent with the side effects

observed in the company's narcolepsy clinical trials.

Clinical investigators are expected to report results of these studies at

appropriate medical meetings later this year. Cephalon is

currently conducting a large-scale study of Provigil in adults with attention

deficit/hyperactivity disorder (ADHD) and, if

successful, will begin a clinical program to test Provigil in children with

ADHD. In addition, the company is conducting clinical

studies with Provigil in patients with EDS resulting from sleep disorders or

fatigue associated with certain neurological diseases.

Provigil is approved by the U.S. Food and Drug Administration to improve

wakefulness in patients with EDS associated with

narcolepsy. The most common side effects associated with Provigil in treating

EDS associated with narcolepsy include nausea,

infection, nervousness, anxiety and insomnia.