This will be an 8-week randomized, double blind, placebo controlled treatment effectiveness study. Armodafinil (NuvigilTM
) is an isomer of a drug called modafinil (ProvigilTM
) that is currently approved by the FDA for the treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder…Armodafinil is felt to be a cleaner, safer, more potent isomer.
Theoretically, "fatigue is interpreted and possibly dictated centrally, and armodafinil's proposed mechanism (similar to that of modafinil) of elevating central histamine activity may allow the brain to interpret a lower fatigue state, thus allowing patients to function better during the day with less peripheral fatigue." The research hypothesis is that the drug will reduce fatigue 30% in the majority of subjects, and will be well tolerated.
For trial details and contact information, see the ClinicalTrials.gov listing for this study - # NCT00568919 - at http://www.clinicaltrials.gov/ct2/show/NCT00568919?term=fatigue&rank=18