Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Missouri, Kansas City
• Collaborator: University of Kansas
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• relapsing remitting and secondary progressive MS patients

• between the ages of 18 and 60

• report cognitive difficulties.

• perform 1 sd or more below cut-off on cognitive screening measure

Exclusion Criteria:

• no history of alcohol/drug abuse or nervous system disorder other than MS

• no sensory impairments that might interfere significantly with cognitive testing

• no developmental history of learning disability or attention-deficit/hyperactivity disorder

• no medical condition other than MS that could substantially affect cognition

• no relapse and/or corticosteroid use within four weeks of assessment;

• no current use of modafinil, armodafinil or other psychostimulants.