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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981084
• Other study ID #: C10953/6113
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 18, 2009
• Last updated: August 6, 2013
• Start date: September 2009
• Est. completion date: April 2011

Study information

• Verified date: August 2013
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• armodafinil
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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No