Clinical trial NCT00981084: Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
Official title: The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2009-09-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Learning and Memory Measures.
timeFrame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
measure: CPT -Test of Information Processing Speed
timeFrame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
measure: Stroop
timeFrame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
measure: Word Generation
timeFrame: Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores.
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Missouri, Kansas City
name: Jared M Bruce, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Sharon Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References: