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

NCT ID: NCT00981084

Last Updated: 2013-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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armodafinil and placebo

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

Group Type EXPERIMENTAL

armodafinil

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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NuVigil

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas

OTHER

Sponsor Role collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jared M Bruce, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Sharon Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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C10953/6113

Identifier Type: -

Identifier Source: org_study_id