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

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: armodafinil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: armodafinil and placebo<br>All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design | Drug: armodafinil<br>* Half of the patients will be randomized to receive a single oral dose of 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.<br>* Other names: NuVigil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning and Memory Measures. | Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12). | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. | 
| CPT -Test of Information Processing Speed | Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores. Continuous Performance Test (CPT) - Vigilance and reaction time. | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. | 
| Stroop | Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. | 
| Word Generation | Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |