Phase 2
N=80
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00806260 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: 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. — 1.57; 1.90; 1.67; 1.88 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VI-0521 (Drug); Placebo (Drug); Alcohol (Other); alcohol placebo (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- VIVUS LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
1.57; 1.90; 1.67; 1.88; 1.62; 1.68 | — |
| PRIMARY 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. |
1.69; 1.64; 1.65; 1.64; 1.67; 1.60 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00806260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.