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

This study has been completed.
Sponsor:
Collaborator:
MDS Pharma Services
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00806260
First received: December 9, 2008
Last updated: August 1, 2013
Last verified: August 2013

December 9, 2008
August 1, 2013
December 2008
May 2009   (final data collection date for primary outcome measure)
  • 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% ] [ Designated as safety issue: No ]

    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. [ Time Frame: Hour 2 and Hour 6 ] [ Designated as safety issue: No ]

    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 Test, assessed by reaction time for correct responses and coordination error, in subjects treated with VI-0521 compared to placebo. [ Time Frame: Beginning, middle, end of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00806260 on ClinicalTrials.gov Archive Site
Not Provided
Additional measures of psychomotor function supporting the primary endpoint including: Reaction time, attention, and information processing speed [ Time Frame: Beginning, middle, end of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Overweight
  • Obesity
  • Drug: VI-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
  • Drug: Placebo
    Placebo daily for 4 weeks
  • Other: Alcohol
  • Other: alcohol placebo
    fruit juice
  • Experimental: Treatment 1
    Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
    Interventions:
    • 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
    Interventions:
    • Drug: VI-0521
    • Drug: Placebo
    • Other: alcohol placebo
  • Experimental: Treatment 3
    First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
    Interventions:
    • Drug: VI-0521
    • Drug: Placebo
    • Other: Alcohol
  • Experimental: Treatment 4
    First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
    Interventions:
    • Drug: VI-0521
    • Drug: Placebo
    • Other: alcohol placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00806260
OB-205
No
VIVUS, Inc.
VIVUS, Inc.
MDS Pharma Services
Study Director: Craig Peterson VIVUS, Inc.
Principal Investigator: Alan Marion, MD MDS Pharma Services
VIVUS, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP