Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00981084 · ClinicalTrials.gov registry record · Phase 2
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
A Phase 2 study, sponsored by University of Missouri, Kansas City.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT00981084 is a Phase 2 study that has completed, run by University of Missouri, Kansas City. The registered enrollment target is 33 participants.
The verdict
NCT00981084, a Phase 2 study, has completed, sponsored by University of Missouri, Kansas City.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study 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.
Interventions
- DRUG armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00981084
The ClinicalTrials.gov registry entry for NCT00981084 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri, Kansas City, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which armodafinil is the first listed.
NCT00981084 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00981084 about?
NCT00981084 is a clinical study titled "Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)". 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 belo...
What is the current status of trial NCT00981084?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2009-09. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00981084?
The interventions under investigation include: armodafinil (DRUG).
Who is sponsoring clinical trial NCT00981084?
This trial is sponsored by University of Missouri, Kansas City, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.