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Phase 3 N=33 Randomized Triple-blind Treatment

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

Multiple Sclerosis

Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Learning and Memory Measures. — -3.38; -.07; -1.38; 1.93 Items recalled — p== .19

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
armodafinil (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Missouri, Kansas City
Primary completion
Apr 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Learning and Memory Measures.
-3.38; -.07; -1.38; 1.93; .88; -1.57 = .19
PRIMARY
CPT -Test of Information Processing Speed
-1.18; 15.04 .33
PRIMARY
Stroop
-1.69; -2.86 .37
PRIMARY
Word Generation
-.69; -1.71 .53

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00981084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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