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Completed

NCT Number: NCT00981084

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Armodafinil

Drug

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

Primary outcomes

  1. Learning and Memory Measures.

    Time frame: 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).

  2. CPT -Test of Information Processing Speed

    Time frame: 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.

  3. Stroop

    Time frame: 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.

  4. Word Generation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Collaborators

  • University of Kansas

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2009
Registry last updated
Oct 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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