OverweightPhase 2NCT00806260

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

A Phase 2 study testing VI-0521 and Alcohol in people with Overweight and Obesity, run by VIVUS LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Overweight, Obesity
What is being tested?: VI-0521 and Alcohol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Dec 2008to May 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Lincoln, Nebraska, 68502

Other trials in United States

About this study

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.

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
Being tested: VI-0521, Placebo, Alcohol, alcohol placebo
Keywords: Overweight, Obesity, coordination, psychomotor
Medical subject headings: Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VI-0521Drug
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
PlaceboDrug
Placebo daily for 4 weeks
AlcoholOther
alcohol placeboOther
fruit juice

Study groups in NCT00806260
Study group	Role	What they receive
Treatment 1	Experimental	Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo Receives: 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 Receives: Drug: VI-0521; Drug: Placebo; Other: alcohol placebo
Treatment 3	Experimental	First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 Receives: Drug: VI-0521; Drug: Placebo; Other: Alcohol
Treatment 4	Experimental	First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521 Receives: Drug: VI-0521; Drug: Placebo; Other: alcohol placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Hour 2 and Hour 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2008May 2009

First posted10 Dec 2008 (estimated)
Study startDec 2008
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OverweightStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00806260
Sponsor's protocol ID: OB-205
Status last verified: Aug 2013
First submitted: 9 Dec 2008
Last updated: 13 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00806260
Acronym / sponsor ID: OB-205
Conditions: Overweight, Obesity
Keywords: Overweight, Obesity, coordination, psychomotor
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Collaborators: MDS Pharma Services
Study start: Dec 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 10 Dec 2008 (estimated)
Results: Posted 13 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Treatment 1	Experimental	Drug: VI-0521, Drug: Placebo, Other: AlcoholDosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
Treatment 2	Experimental	Drug: VI-0521, Drug: Placebo, Other: alcohol placeboFirst dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
Treatment 3	Experimental	Drug: VI-0521, Drug: Placebo, Other: AlcoholFirst dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
Treatment 4	Experimental	Drug: VI-0521, Drug: Placebo, Other: alcohol placeboFirst dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521

Who may qualify

Ages: 21 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VI-0521Phentermine 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	Treatment 1, Treatment 2, Treatment 3, Treatment 4
PlaceboPlacebo daily for 4 weeks	Drug	Treatment 1, Treatment 2, Treatment 3, Treatment 4
Alcohol	Other	Treatment 1, Treatment 3
alcohol placebofruit juice	Other	Treatment 2, Treatment 4

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 13 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alcohol, VI-0521 Placebo Then VI-0521	15	15
Alcohol, VI-0521 Then VI-0521 Placebo	8	8
Alcohol-placebo, VI-0521-placebo Then VI-0521	8	8
Alcohol-placebo, VI-0521 Then VI-0521-placebo	14	14
Alcohol Only	18	15
Alcohol-placebo Only	17	17

Primary outcome: 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%. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Period 1 Alcohol-placebo n = 23	Period 1 Alcohol n = 23
Breath Alcohol Level 0.10%	1.57 (0.06)	1.90 (0.06)
Breath Alcohol Level 0.07%	1.67 (0.04)	1.88 (0.05)
Breath Alcohol Level 0.04%	1.62 (0.05)	1.68 (0.05)

Period 1 Alcohol-placebo vs Period 1 Alcohol: Mean Difference (Final Values): 0.33, ANCOVA
Period 1 Alcohol-placebo vs Period 1 Alcohol: Mean Difference (Final Values): 0.21, ANCOVA
Period 1 Alcohol-placebo vs Period 1 Alcohol: Mean Difference (Final Values): 0.06, ANCOVA

Population analysed: modified-intent-to-treat (mITT)

Primary outcome: 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. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Period 2 VI-0521-placebo n = 36	Period 2 VI-0521 n = 36	Period 3 VI-0521-placebo n = 36	Period 3 VI-0521 n = 36
Hour 2	1.69 (0.04)	1.64 (0.04)	1.65 (0.04)	1.64 (0.04)
Hour 6	1.67 (0.04)	1.60 (0.04)	1.65 (0.03)	1.60 (0.03)

Period 2 VI-0521-placebo vs Period 2 VI-0521: Mean Difference (Final Values): -0.05 (95% CI -0.17 to 0.07), ANCOVA
Period 2 VI-0521-placebo vs Period 2 VI-0521: Mean Difference (Final Values): -0.07 (95% CI -0.18 to 0.04), ANCOVA
Period 3 VI-0521-placebo vs Period 3 VI-0521: Mean Difference (Final Values): -0.01 (95% CI -0.08 to 0.06), ANCOVA

Population analysed: Intent-to-treat (ITT) ITT population includes participants who completed Periods 1, 2 and 3. Subjects that were discontinued due to adverse events, failed drug/alcohol screens, non-compliance, etc. are not included in this analysis.

Adverse events

Time frame: AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Period 1 Placebo	0 of 39 (0%)	5 of 39 (12.8%)	Not reported
Period 1 Alcohol	0 of 41 (0%)	22 of 41 (53.7%)	Not reported
Period 2 and 3 Placebo	0 of 42 (0%)	11 of 42 (26.2%)	Not reported
Period 2 and 3 Qnexa	0 of 39 (0%)	14 of 39 (35.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Craig Peterson study director

VIVUS LLC

Alan Marion, MD principal investigator

MDS Pharma Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VI-0521 and Alcohol in people with Overweight and Obesity, run by VIVUS LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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%). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013; AzTrials last refreshed its copy on 30 Oct 2026.