Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
- Registration Number
- NCT00981084
- Lead Sponsor
- University of Missouri, Kansas City
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description armodafinil and placebo armodafinil All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
- Primary Outcome Measures
Name Time Method Learning and Memory Measures. Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. 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).CPT -Test of Information Processing Speed Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. 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.Word Generation Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. 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.
Stroop Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States