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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00981084

Run by

University of Missouri, Kansas City

People needed

33

Starts

2009-09-01

Expected to finish

2011-04-01

Last updated by the study team

2013-10-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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