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| Name | Class |
|---|---|
| MDS Pharma Services | INDUSTRY |
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The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo |
|
| Treatment 2 | Experimental | First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521 |
|
| Treatment 3 | Experimental | First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 |
|
| Treatment 4 | Experimental | First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-0521 | Drug | Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1. | CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment. | at breath alcohol levels 0.10%, 0.07%, and 0.04% |
| Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3. | CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment. | Hour 2 and Hour 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Peterson | VIVUS LLC | Study Director |
| Alan Marion, MD | MDS Pharma Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Lincoln | Nebraska | 68502 | United States |
Period 1 was not a crossover design. Subjects were randomized to either alcohol or alcohol-placebo. Subjects who completed Period 1 were then randomized to the crossover portion of the study, Periods 2 and 3.
Subject recruitment occurred within the US between January 2009 and March 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcohol, VI-0521 Placebo Then VI-0521 | Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three. |
| FG001 | Alcohol, VI-0521 Then VI-0521 Placebo | Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three. |
| FG002 | Alcohol-placebo, VI-0521-placebo Then VI-0521 | Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three. |
| FG003 | Alcohol-placebo, VI-0521 Then VI-0521-placebo | Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three. |
| FG004 | Alcohol Only | Alcohol was administered during period one after which the subject's participation ended. |
| FG005 | Alcohol-placebo Only | Alcohol-placebo was administered during period one after which the subject's participation ended. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (1 Day) |
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| Period 2 |
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| Period 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol, VI-0521 Placebo Then VI-0521 | Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3. |
| BG001 | Alcohol, VI-0521 Then VI-0521 Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1. | CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment. | modified-intent-to-treat (mITT) | Posted | Nov 2010 | Least Squares Mean | Standard Error | scores on a scale | at breath alcohol levels 0.10%, 0.07%, and 0.04% |
AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
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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 | Period 1 Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
Due to technical issues, an additional cohort of subjects were added to Period 1 only, which produced two additional treatment arms, alcohol only and alcohol placebo only. No change was made in the data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wesley W Day, PhD | Vivus, Inc. | 650-934-5200 | day@vivus.com |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo daily for 4 weeks |
|
| Alcohol | Other |
|
| alcohol placebo | Other | fruit juice |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
| BG002 | Alcohol Placebo, VI-0521 Placebo Then VI-0521 | Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3. |
| BG003 | Alcohol Placebo, VI-0521 Then VI-0521 Placebo | Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3. |
| BG004 | Alcohol Only | Subjects in this study arm only participated in period 1 and were given alcohol. |
| BG005 | Alcohol Placebo Only | Subject in this study arm only participated in period 1 and were given alcohol placebo. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Period 1 Alcohol-placebo | fruit juice |
| OG001 | Period 1 Alcohol | Alcohol |
|
|
|
| Primary | Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3. | CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy [PFNACC]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination [PFNCOOR]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment. | Intent-to-treat (ITT) ITT population includes participants who completed Periods 1, 2 and 3. Subjects that were discontinued due to adverse events, failed drug/alcohol screens, non-compliance, etc. are not included in this analysis. | Posted | Nov 2010 | Least Squares Mean | Standard Error | scores on a scale | Hour 2 and Hour 6 |
|
|
|
|
| 0 |
| 39 |
| 5 |
| 39 |
| EG001 | Period 1 Alcohol | 0 | 41 | 22 | 41 |
| EG002 | Period 2 and 3 Placebo | Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population. | 0 | 42 | 11 | 42 |
| EG003 | Period 2 and 3 Qnexa | The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population. | 0 | 39 | 14 | 39 |
| dry mouth | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| pain | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| disturbance in attention | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| parethesia | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution & PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hour 6 |
|
at 6 hr timepoint
| ANCOVA |
| Mean Difference (Final Values) |
| -0.07 |
| Standard Error of the Mean |
| 0.05 |
| 2-Sided |
| 95 |
| -0.18 |
| 0.04 |
| Yes |
| Non-Inferiority or Equivalence |
non inferiority test |
| at 2 hr timepoint | ANCOVA | Mean Difference (Final Values) | -0.01 | Standard Error of the Mean | 0.03 | 2-Sided | 95 | -0.08 | 0.06 | Yes | Non-Inferiority or Equivalence | non inferiority |
| at 6 hr timepoint | ANCOVA | Mean Difference (Final Values) | -0.04 | Standard Error of the Mean | 0.04 | 2-Sided | 95 | -0.13 | 0.05 | Yes | Non-Inferiority or Equivalence | non inferiority |