Cephalon markets the drug Provigil, also known as modafinil. Modafinil is a central nervous system stimulant and is approved by the Food and Drug Administration for treating sleep disorders. Parkinson's is a degenerative disease of the central nervous system. The primary symptoms of Parkinson's disease are muscle rigidity, tremors, gait abnormalities, speech impairment and a generalized slowness of physical movements. Secondary features of Parkinson's disease are cognitive and behavioral problems, excessive sleepiness and fatigue.
Sleepiness
Multiple, small, human studies have shown that modafinil reduces sleepiness in patients with Parkinson's disease, although in others it did not demonstrate such an effect. A study published in the April 2010 issue of "Neuropsychiatric Disease and Treatment" found that modafinil administered twice per day at doses of 100 mg decreased sleepiness and improved alertness in elderly patients with Parkinson's. This study also noted it was relatively safe and did not cause significant adverse effects. Another study in the December 2005 issue of the "Journal of Neurology, Neurosurgery and Psychiatry" did not find that modafinil affected daytime sleepiness in patients with Parkinson's.
Fatigue
Over 50 percent of people with Parkinson's experience chronic fatigue. A study reported in the November 2009 issue of "Clinical Neuropharmacology" stated that modafinil reduced fatigue associated with movement, but it did not influence fatigue symptoms.
Neuroprotection
Parkinson's disease is characterized by a chronic-progressive degeneration of the central nervous system. Although no human studies are available, a study published in the January 2008 issue of "Brain Research" showed that modafinil protects against central nervous system damage in an animal model of Parkinson's.
Warnings
The Food and Drug Administration has classified modafinil as a controlled substance because of its potential for misuse. Also, the National Library of Medicine reports on its website, DailyMed, that serious rashes have been reported in children who were administered modafinil during clinical trial studies. The occurrence is approximately 0.8 percent. In adult clinical trials, no serious skin rashes were reported, but cases of serious skin rashes were reported after the drug was marketed. According to the report on DailyMed, modafinil treatment has rarely been associated with exacerbating mood disorders, but it should be used cautiously in people with a history of psychosis, depression or mania.
References
- DailyMed: PROVIGIL (modafinil) tablet
- "Neuropsychiatric Disease and Treatment"; Daytime sleepiness in elderly Parkinson's disease patients and treatment with the psychostimulant modafinil: A preliminary study; Johan Lökk; April 2010
- "Journal of Neurology, Neurosurgery and Psychiatry"; Modafinil for daytime somnolence in Parkinson's disease: double blind, placebo controlled parallel trial; W. Ondo et al.; December 2005
- "Clinical Neuropharmacology"; Using modafinil to treat fatigue in Parkinson disease: a double-blind, placebo-controlled pilot study; J.S. Lou; Nov-Dec 2009
- "Brain Research"; Exploring the Neuroprotective Effects of Modafinil in a Marmoset Parkinson Model with Immunohistochemistry, Magnetic Resonance Imaging and Spectroscopy; S. A. van Vliet et al.; January 2008
