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

NCT00806260 | Completed Phase 2 Results

• 1 other identifier: OB-205
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; coordination; psychomotor

Outcome Measures

Primary Outcomes (2)

• 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.

  at breath alcohol levels 0.10%, 0.07%, and 0.04%

• 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.

  Hour 2 and Hour 6

Study Arms (4)

Treatment 1

EXPERIMENTAL

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

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

Treatment 2

EXPERIMENTAL

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

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

Treatment 3

EXPERIMENTAL

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

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

Treatment 4

EXPERIMENTAL

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

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

Interventions

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

Treatment 1; Treatment 2; Treatment 3; Treatment 4

Placebo DRUG

Placebo daily for 4 weeks

Treatment 1; Treatment 2; Treatment 3; Treatment 4

Alcohol OTHER

Treatment 1; Treatment 3

alcohol placebo OTHER

fruit juice

Treatment 2; Treatment 4

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VIVUS LLC: lead
• MDS Pharma Services: collaborator

Study Sites (1)

Research Site

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

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.

Results Point of Contact

• Title: Wesley W Day, PhD
• Organization: Vivus, Inc.

day@vivus.com

650-934-5200

Study Officials

• Craig Peterson

  VIVUS LLC

  STUDY DIRECTOR

• Alan Marion, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: December 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 13, 2013
• Results First Posted: September 13, 2013

Record last verified: 2013-08

Locations

US (1)