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Completed

NCT Number: NCT00806260

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

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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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Placebo

Drug

Placebo daily for 4 weeks

Alcohol

Other

alcohol placebo

Other

fruit juice

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.

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

    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.

  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.

    Time frame: Hour 2 and Hour 6

    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.

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Collaborators

  • MDS Pharma Services

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 10, 2008
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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