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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: armodafinil

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: NuVigil

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Missouri, Kansas City
• Collaborators: University of Kansas
• Investigators: Principal Investigator: Jared M Bruce, PhD, University of Missouri, Kansas City; Principal Investigator: Sharon Lynch, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 18, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Estimate): October 14, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: C10953/6113