Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
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.
Timeline
- Start
- 2009-09
- Primary completion
- 2011-04
- Completion
- 2011-04
Outcome
Mixed primary results
registry MEAN Placebo/Armofafinil: Aditory Verbal Learning Test Delay: -1.38 (Standard Deviation 1.89) Items recalled NCT00981084 ↗
registry MEAN Armodafinil/Placebo: Aditory Verbal Learning Test Delay: 1.93 (Standard Deviation 2.70) Items recalled NCT00981084 ↗
registry analysis (superiority or other test); Placebo/Armofafinil vs Armodafinil/Placebo; p = .0005; t-test, 2 sided NCT00981084 ↗
registry analysis (superiority or other test); Placebo/Armofafinil vs Armodafinil/Placebo; p = .33; t-test, 2 sided NCT00981084 ↗
registry analysis (superiority or other test); Placebo/Armofafinil vs Armodafinil/Placebo; p = .37; t-test, 2 sided NCT00981084 ↗
registry analysis (superiority or other test); Placebo/Armofafinil vs Armodafinil/Placebo; p = .53; t-test, 2 sided NCT00981084 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Armodafinil | Small molecule | 250 mg | Oral |