OBJECTIVE: Examine the efficacy of armodafinil in improving cognition in MSers.
BACKGROUND: Many MSers experience cognitive difficulties. Armodafinil has shown promise as a cognitive enhancer in other patient populations. No studies have examined whether armodafinil improves cognition in MSers.
METHODS: A double-blind, placebo-controlled, crossover study testing the efficacy of armodafinil in reducing cognitive problems in MSers was conducted. 17 MSers were randomised to receive a dose of lactose placebo about 2 hours before they underwent a neuropsychological testing session. After a week-long washout period, we gave them a single 250-mg dose of armodafinil about 2 hours before testing them a second time. We randomized another 16 MSers to receive the active drug first, then the placebo. We excluded 3 of the participants before analyzing the data.
RESULTS: After correcting for multiple comparisons of the 8 neuropsychological dependent measures, MSers had significantly improved delayed memory on a list-learning task after they took armodafinil (P=0.0005), but no improvement on measures of executive function, visual memory, processing speed, or self-reported fatigue.
CONCLUSIONS: Results provide preliminary evidence that armodafinil may improve delayed verbal recall in MSers. A larger trial showing enhanced memory among MSers taking long-term armodafinil could serve as a foundation for its possible clinical use as a memory enhancer in MSers.
structure of Armodafinil
“This is a small cross-over study showing that the stimulant Armodafinil improves cognition in MSers. It will now have to be tested in a larger group of MSers, probably at multiple doses, to confirm the study results. If positive it may then be taken forward in two large phase 3 studies in MSers to allow registration. Let’s hope the company Teva, who has Armodafinil, on it books will develop it for MSers. I suspect, however, this may not happen as the patent on Armodafinil is relatively short and looks to expire in 2016. There has already been litigation between Teva, who acquired the rights to Armodafanil when they bought Cephalon, and Mylan a big generics company (see press article).”
“A lot of you may already be on modafinil (Provigil) for fatigue. Some MSers who take modafinil report improvement in their cognitive functioning. Would you agree with this?”
“Armodafinil (Nuvigil) is a stimulant-like drug. Armodafinil is an enantiopure drug consisting of just the active (−)-(R)-enantiomer of the racemic drug modafinil (Provigil). The racemate in modafinil will have (+) and (-) versions of the compound. So hidden in the chemistry of this compound are two drugs. These racimic drugs have a chemical structure where
some of the bonds are flexible and so some of the chemical groups can
point in one direction or the opposite direction. In some circumstances the different versions can have different properties and hence you have to show that the particular version of the drug is active. Racemic drugs often allow Pharma companies to the option of developing a new drug if they has similar modes of action. To this however you have to develop the enantiomer from scratch!”
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