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

This study has been completed.
Sponsor:
Collaborator:
University of Kansas
Information provided by (Responsible Party):
University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT00981084
First received: September 18, 2009
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: armodafinil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study

Resource links provided by NLM:


Further study details as provided by University of Missouri, Kansas City:

Primary Outcome Measures:
  • Learning and Memory Measures. [ Time Frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. ] [ Designated as safety issue: No ]

    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 [ Time Frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. ] [ Designated as safety issue: No ]

    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.


  • Stroop [ Time Frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. ] [ Designated as safety issue: No ]
    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.

  • Word Generation [ Time Frame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. ] [ Designated as safety issue: No ]
    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.


Enrollment: 33
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NuVigil

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981084

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Missouri, Kansas City
University of Kansas
Investigators
Principal Investigator: Jared M Bruce, PhD University of Missouri, Kansas City
Principal Investigator: Sharon Lynch, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT00981084     History of Changes
Other Study ID Numbers: C10953/6113
Study First Received: September 18, 2009
Results First Received: April 22, 2013
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 28, 2014