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CompletedNCT00806260Updated Sep 13, 2013Results posted

A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.

A Phase 2 interventional study of VI-0521 and Placebo in Overweight and Obesity, sponsored by VIVUS LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-13.

Sponsored by VIVUS LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overweight
  • Obesity

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Keywords

  • Overweight
  • Obesity
  • coordination
  • psychomotor
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 80 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

VIVUS LLC is the lead sponsor of 40 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Written consents;
  • Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
  • Healthy obese or overweight subjects with BMI between 27 and 35.

Exclusion criteria

Exclusion Criteria:

  • History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
  • Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
  • History of drug abuse during the three years prior to screening;
  • History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
  • Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
  • More than one lifetime episode of major depression;
  • Currently working night shifts at a job;
  • On average consumes greater than two cups of coffee or xanthine-containing beverages per day (>200 mg/day) within the two weeks prior to screening;
  • Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
  • Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN;
  • Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Treatment 1

    Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo

    Drug: VI-0521 · Drug: Placebo · Other: Alcohol

  • Experimental
    Treatment 2

    First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521

    Drug: VI-0521 · Drug: Placebo · Other: alcohol placebo

  • Experimental
    Treatment 3

    First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521

    Drug: VI-0521 · Drug: Placebo · Other: Alcohol

  • Experimental
    Treatment 4

    First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521

    Drug: VI-0521 · Drug: Placebo · Other: alcohol placebo

Interventions

  • DrugVI-0521

    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

  • DrugPlacebo

    Placebo daily for 4 weeks

  • OtherAlcohol
  • Otheralcohol placebo

    fruit juice

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at breath alcohol levels 0.10%, 0.07%, and 0.04%

  2. 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.

    Time frame: Hour 2 and Hour 6

07

Results

Posted Sep 13, 2013
Limitations and caveats
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.

Participant flow

Subject recruitment occurred within the US between January 2009 and March 2009

Period 1 (1 Day)
Participant flow — Period 1 (1 Day)
MilestoneAlcohol, VI-0521 Placebo Then VI-0521Alcohol, VI-0521 Then VI-0521 PlaceboAlcohol-placebo, VI-0521-placebo Then VI-0521Alcohol-placebo, VI-0521 Then VI-0521-placeboAlcohol OnlyAlcohol-placebo Only
Started1588141817
Completed1588141517
Not completed000030
Withdrew: Adverse event000030
Period 2
Participant flow — Period 2
MilestoneAlcohol, VI-0521 Placebo Then VI-0521Alcohol, VI-0521 Then VI-0521 PlaceboAlcohol-placebo, VI-0521-placebo Then VI-0521Alcohol-placebo, VI-0521 Then VI-0521-placeboAlcohol OnlyAlcohol-placebo Only
Started15881400
Completed13861200
Not completed202200
Withdrew: Adverse event000100
Withdrew: Protocol violation101000
Withdrew: Need to take concomitant medication100000
Withdrew: Sponsor request001100
Period 3
Participant flow — Period 3
MilestoneAlcohol, VI-0521 Placebo Then VI-0521Alcohol, VI-0521 Then VI-0521 PlaceboAlcohol-placebo, VI-0521-placebo Then VI-0521Alcohol-placebo, VI-0521 Then VI-0521-placeboAlcohol OnlyAlcohol-placebo Only
Started13861200
Completed12751200
Not completed111000
Withdrew: Protocol violation011000
Withdrew: Pregnancy100000

Outcome measures

PrimaryMeasure 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.

Time frame:
at breath alcohol levels 0.10%, 0.07%, and 0.04%
Reported as:
Least squares mean · scores on a scale
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.
scores on a scalePeriod 1 Alcohol-placeboPeriod 1 Alcohol
Breath Alcohol Level 0.10%1.57 ± 0.061.90 ± 0.06
Breath Alcohol Level 0.07%1.67 ± 0.041.88 ± 0.05
Breath Alcohol Level 0.04%1.62 ± 0.051.68 ± 0.05
Statistical analysis
  • Period 1 Alcohol-placebo vs Period 1 Alcohol · ANCOVA · Mean difference (final values): 0.33
  • Period 1 Alcohol-placebo vs Period 1 Alcohol · ANCOVA · Mean difference (final values): 0.21
  • Period 1 Alcohol-placebo vs Period 1 Alcohol · ANCOVA · Mean difference (final values): 0.06
PrimaryMeasure 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.

Time frame:
Hour 2 and Hour 6
Reported as:
Least squares mean · scores on a scale
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.
scores on a scalePeriod 2 VI-0521-placeboPeriod 2 VI-0521Period 3 VI-0521-placeboPeriod 3 VI-0521
Hour 21.69 ± 0.041.64 ± 0.041.65 ± 0.041.64 ± 0.04
Hour 61.67 ± 0.041.60 ± 0.041.65 ± 0.031.60 ± 0.03
Statistical analysis
  • Period 2 VI-0521-placebo vs Period 2 VI-0521 · ANCOVA · Mean difference (final values): -0.05 · 95% CI -0.17 to 0.07
  • Period 2 VI-0521-placebo vs Period 2 VI-0521 · ANCOVA · Mean difference (final values): -0.07 · 95% CI -0.18 to 0.04
  • Period 3 VI-0521-placebo vs Period 3 VI-0521 · ANCOVA · Mean difference (final values): -0.01 · 95% CI -0.08 to 0.06
  • Period 3 VI-0521-placebo vs Period 3 VI-0521 · ANCOVA · Mean difference (final values): -0.04 · 95% CI -0.13 to 0.05

Adverse events

Collected over AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Period 1 Placebo—0/39 (0%)5/39 (12.8%)
Period 1 Alcohol—0/41 (0%)22/41 (53.7%)
Period 2 and 3 Placebo—0/42 (0%)11/42 (26.2%)
Period 2 and 3 Qnexa—0/39 (0%)14/39 (35.9%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventPeriod 1 PlaceboPeriod 1 AlcoholPeriod 2 and 3 PlaceboPeriod 2 and 3 Qnexa
headacheNervous system disorders3/3911/410/424/39
nauseaGastrointestinal disorders2/398/410/420/39
dry mouthGastrointestinal disorders0/391/412/424/39
parethesiaNervous system disorders0/390/412/424/39
pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders0/394/411/420/39
hiccupsRespiratory, thoracic and mediastinal disorders0/393/410/420/39
rhinorrheaRespiratory, thoracic and mediastinal disorders0/390/413/421/39
sinus congestionRespiratory, thoracic and mediastinal disorders0/390/413/420/39
diarrheaGastrointestinal disorders2/392/411/421/39
dyspepsiaGastrointestinal disorders0/390/410/422/39

Baseline characteristics

Age Continuous
Age Continuous(years)Alcohol, VI-0521 Placebo Then VI-0521Alcohol, VI-0521 Then VI-0521 PlaceboAlcohol Placebo, VI-0521 Placebo Then VI-0521Alcohol Placebo, VI-0521 Then VI-0521 PlaceboAlcohol OnlyAlcohol Placebo OnlyTotal
Mean26.7 ± 5.429.9 ± 7.831.1 ± 8.627.4 ± 6.130.1 ± 7.727.4 ± 6.328.5 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)Alcohol, VI-0521 Placebo Then VI-0521Alcohol, VI-0521 Then VI-0521 PlaceboAlcohol Placebo, VI-0521 Placebo Then VI-0521Alcohol Placebo, VI-0521 Then VI-0521 PlaceboAlcohol OnlyAlcohol Placebo OnlyTotal
Female51167121
Male10778111659
Region of Enrollment
Region of Enrollment(participants)Alcohol, VI-0521 Placebo Then VI-0521Alcohol, VI-0521 Then VI-0521 PlaceboAlcohol Placebo, VI-0521 Placebo Then VI-0521Alcohol Placebo, VI-0521 Then VI-0521 PlaceboAlcohol OnlyAlcohol Placebo OnlyTotal
United States158814181780
08

Study locations

1 site
  • Research Site
    Lincoln, Nebraska 68502, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00806260
Lead sponsor
VIVUS LLC
Collaborators
MDS Pharma Services
Responsible party
Sponsor
First posted
Dec 10, 2008
Start date
Dec 2008
Primary completion
May 2009
Completion
May 2009
Results posted
Sep 13, 2013
Last update
Sep 13, 2013

Study contacts

Craig Peterson
study director · VIVUS LLC
Alan Marion, MD
principal investigator · MDS Pharma Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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