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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 18, 2009 | ||||||||
| Last Updated Date | February 8, 2012 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00981084 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS) | ||||||||
| Official Title ICMJE | The Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis: a Double-Blind Randomized Crossover Study | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Multiple Sclerosis | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: armodafinil and placebo
All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
Intervention: Drug: armodafinil |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 32 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00981084 | ||||||||
| Other Study ID Numbers ICMJE | C10953/6113 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Missouri, Kansas City | ||||||||
| Study Sponsor ICMJE | University of Missouri, Kansas City | ||||||||
| Collaborators ICMJE | University of Kansas | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Missouri, Kansas City | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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