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| Name | Class |
|---|---|
| University of Kansas | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| armodafinil and placebo | Experimental | All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| armodafinil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Learning and Memory Measures. | Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12). | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
| CPT -Test of Information Processing Speed | Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores. Continuous Performance Test (CPT) - Vigilance and reaction time. | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
| Stroop | Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
| Word Generation | Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared M Bruce, PhD | University of Missouri, Kansas City | Principal Investigator |
| Sharon Lynch, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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Participants who demonstrated at least mild cognitive impairment on a screening measure were recruited from a large MS neurology clinic in the Midwest from 2009 to 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Armodafinil First and Placebo Second | Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms. |
| FG001 | Placebo First and Armodafinil Second | Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (One Day) |
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| Washout Period (7 Days) |
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| Second Intervention (One Day) |
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| Post Intervention (Data Analysis) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Armodafinil Then Placebo | All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Learning and Memory Measures. | Testing was completed after first intervention and again after second intervention. Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. Rey Auditory Verbal Learning Test (RAVLT)- Measure of Verbal Learning (Min = 0; Max = 75). RAVLT Delay - Measure of Delayed Verbal Recall (Min = 0; Max = 15). Brief Visuospatial Memory Test (BVMT) Learning - Measure of Visual Learning (Min = 0; Max = 36). BVMT Delay - Measure of Delayed Visual Recall (Min = 0; Max = 12). | Posted | Mean | Standard Deviation | Items recalled | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Then Armodafinil (Placebo) | Adverse events reported after taking placebo in the Placebo then Armodafinil Group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sleep difficulties | Nervous system disorders | Non-systematic Assessment | participants reported some difficulty falling asleep |
A small pilot trial with only one dose of drug administered. Limitations include the very small sample and the use of a single-dose cross-over design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jared Bruce | University of Missouri - Kansas City | 401-499-4043 | brucejm@umkc.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| NOT COMPLETED |
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| BG001 | Placebo Then Armodafinil |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Armodafinil/Placebo | armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores. |
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| Primary | CPT -Test of Information Processing Speed | Lower scores indicate better perforamnce. Scores from derived by subtracting session 2 scores from session 1 scores. Continuous Performance Test (CPT) - Vigilance and reaction time. | Posted | Mean | Standard Deviation | milliseconds | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
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| Primary | Stroop | Stroop - Test of impulsivity (min = 0, max = none). Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. | Posted | Mean | Standard Deviation | number of colors named | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
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| Primary | Word Generation | Word Generation - Measure of verbal fluency. (Min = 0; No Max. )Higher scores indicate better performance. Scores from derived by subtracting session 2 scores from session 1 scores. | Posted | Mean | Standard Deviation | number of words generated | Outcome was assessed after each intervention (2 time points). Time 2 scores were subtracted from time 1 scores. |
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| 0 |
| 17 |
| 2 |
| 17 |
| EG001 | Armodafinil Then Placebo (Armodafinil) | Adverse events reported after taking armodafinil in the Armodafinil then placebo group | 0 | 16 | 3 | 16 |
| EG002 | Placebo Then Armodafinil (Armodafinil) | Adverse events following armodafinil in the placebo/armodafinil group | 0 | 17 | 2 | 17 |
| EG003 | Armodafinil Then Placebo (Placebo) | number of adverse events following placebo in the armodafniil then placebo condition. | 0 | 16 | 1 | 16 |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |