Status:
COMPLETED
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
Lead Sponsor:
University of Missouri, Kansas City
Collaborating Sponsors:
University of Kansas
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00981084
Start Date
September 1 2009
End Date
April 1 2011
Last Update
October 14 2013
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160