Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
The investigation will involve a double-blind, placebo controlled, cross-over study examining
the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive
fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1
standard deviation below the mean on a brief cognitive screen will be given a thorough
neuropsychological evaluation at two time points. Half of the patients will be randomized to
receive a single oral dose of lactose placebo prior to the first testing session. After a
washout period of one week, they will then receive 250mg of armodafinil prior to a second
testing session (P/A group). The other half of patients will be randomized to receive the
active drug first. After a washout period of one week, they will receive the placebo prior to
a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours
after administration, participants will be asked to take a single 250mg capsule 2 hours prior
to the scheduled testing sessions.