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

NCT00981084 | Completed Phase 2 Results DMC

• 1 other identifier: C10953/6113
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

armodafinil and placebo

EXPERIMENTAL

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

Drug: armodafinil

Interventions

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.

Also known as: NuVigil

armodafinil and placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• University of Kansas: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

A small pilot trial with only one dose of drug administered. Limitations include the very small sample and the use of a single-dose cross-over design.

Results Point of Contact

• Title: Dr. Jared Bruce
• Organization: University of Missouri - Kansas City

brucejm@umkc.edu

401-499-4043

Study Officials

• Jared M Bruce, PhD

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

• Sharon Lynch, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 14, 2013
• Results First Posted: October 14, 2013

Record last verified: 2013-08

Locations

US (1)