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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VI-0521
Placebo
Alcohol
alcohol placebo
Sponsored by
VIVUS LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Obesity, coordination, psychomotor

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment 1

Treatment 2

Treatment 3

Treatment 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2008
Last Updated
August 1, 2013
Sponsor
VIVUS LLC
Collaborators
MDS Pharma Services
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1. Study Identification

Unique Protocol Identification Number
NCT00806260
Brief Title
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Psychomotor Effect of VI-0521 in Healthy Overweight and Obese Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC
Collaborators
MDS Pharma Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, coordination, psychomotor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
Arm Title
Treatment 3
Arm Type
Experimental
Arm Description
First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
Arm Title
Treatment 4
Arm Type
Experimental
Arm Description
First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
Intervention Type
Drug
Intervention Name(s)
VI-0521
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo daily for 4 weeks
Intervention Type
Other
Intervention Name(s)
Alcohol
Intervention Type
Other
Intervention Name(s)
alcohol placebo
Intervention Description
fruit juice
Primary Outcome Measure Information:
Title
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.
Description
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%
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Peterson
Organizational Affiliation
VIVUS LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alan Marion, MD
Organizational Affiliation
MDS Pharma Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States

12. IPD Sharing Statement

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

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