Phase 3
N=33
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT00981084 ↗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
| Outcome | Result | p-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.
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.