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
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Drug: VI-0521
Drug: Placebo
Other: Alcohol
Other: alcohol placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

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. [ 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.



Enrollment: 80
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1
Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
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
Experimental: Treatment 2
First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
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 placebo
fruit juice
Experimental: Treatment 3
First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
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
Experimental: Treatment 4
First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
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 placebo
fruit juice

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806260

Locations
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
VIVUS, Inc.
MDS Pharma Services
Investigators
Study Director: Craig Peterson VIVUS, Inc.
Principal Investigator: Alan Marion, MD MDS Pharma Services
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00806260     History of Changes
Other Study ID Numbers: OB-205
Study First Received: December 9, 2008
Results First Received: July 31, 2012
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Overweight
Obesity
coordination
psychomotor

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014