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

University of Missouri, Kansas City

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: armodafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT00981084

C10953/6113

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 1 patient group

armodafinil and placebo

Experimental group

Description:

All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design

Treatment:

Drug: armodafinil