Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)
This study is enrolling participants by invitation only.
Sponsor:
University of Missouri, Kansas City
Collaborator:
University of Kansas
Information provided by (Responsible Party):
University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT00981084
First received: September 18, 2009
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: armodafinil |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study |
Resource links provided by NLM:
Further study details as provided by University of Missouri, Kansas City:
Primary Outcome Measures:
- Improved performance on neuropsychological testing and reduced cognitive fatigue as measured by self-report [ Time Frame: Assessed twice, once with placebo and once with drug, one week apart ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 32 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: armodafinil and placebo
All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
|
Drug: armodafinil
Half of the patients will be randomized to receive a single oral dose of 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.
Other Name: NuVigil
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981084
Locations
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
Sponsors and Collaborators
University of Missouri, Kansas City
University of Kansas
Investigators
| Principal Investigator: | Jared M Bruce, PhD | University of Missouri, Kansas City |
| Principal Investigator: | Sharon Lynch, MD | University of Kansas |
More Information
No publications provided
| Responsible Party: | University of Missouri, Kansas City |
| ClinicalTrials.gov Identifier: | NCT00981084 History of Changes |
| Other Study ID Numbers: | C10953/6113 |
| Study First Received: | September 18, 2009 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013