Trial Outcomes & Findings for A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects. (NCT NCT00806260)

Last Updated: 2013-09-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

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

Results posted on

2013-09-13

Participant Flow

Subject recruitment occurred within the US between January 2009 and March 2009

Period 1 was not a crossover design. Subjects were randomized to either alcohol or alcohol-placebo. Subjects who completed Period 1 were then randomized to the crossover portion of the study, Periods 2 and 3.

Participant milestones

Participant milestones
Measure	Alcohol, VI-0521 Placebo Then VI-0521 Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.	Alcohol, VI-0521 Then VI-0521 Placebo Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.	Alcohol-placebo, VI-0521-placebo Then VI-0521 Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.	Alcohol-placebo, VI-0521 Then VI-0521-placebo Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.	Alcohol Only Alcohol was administered during period one after which the subject's participation ended.	Alcohol-placebo Only Alcohol-placebo was administered during period one after which the subject's participation ended.
Period 1 (1 Day) STARTED	15	8	8	14	18	17
Period 1 (1 Day) COMPLETED	15	8	8	14	15	17
Period 1 (1 Day) NOT COMPLETED	0	0	0	0	3	0
Period 2 STARTED	15	8	8	14	0	0
Period 2 COMPLETED	13	8	6	12	0	0
Period 2 NOT COMPLETED	2	0	2	2	0	0
Period 3 STARTED	13	8	6	12	0	0
Period 3 COMPLETED	12	7	5	12	0	0
Period 3 NOT COMPLETED	1	1	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Alcohol, VI-0521 Placebo Then VI-0521 Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.	Alcohol, VI-0521 Then VI-0521 Placebo Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.	Alcohol-placebo, VI-0521-placebo Then VI-0521 Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.	Alcohol-placebo, VI-0521 Then VI-0521-placebo Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.	Alcohol Only Alcohol was administered during period one after which the subject's participation ended.
Period 1 (1 Day) Adverse Event	0	0	0	0	3
Period 2 Adverse Event	0	0	0	1	0
Period 2 Protocol Violation	1	0	1	0	0
Period 2 Need to take concomitant medication	1	0	0	0	0
Period 2 sponsor request	0	0	1	1	0
Period 3 Protocol Violation	0	1	1	0	0
Period 3 Pregnancy	1	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alcohol, VI-0521 Placebo Then VI-0521 n=15 Participants Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.	Alcohol, VI-0521 Then VI-0521 Placebo n=8 Participants Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.	Alcohol Placebo, VI-0521 Placebo Then VI-0521 n=8 Participants Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.	Alcohol Placebo, VI-0521 Then VI-0521 Placebo n=14 Participants Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.	Alcohol Only n=18 Participants Subjects in this study arm only participated in period 1 and were given alcohol.	Alcohol Placebo Only n=17 Participants Subject in this study arm only participated in period 1 and were given alcohol placebo.	Total n=80 Participants Total of all reporting groups
Age Continuous	26.7 years STANDARD_DEVIATION 5.4 • n=5 Participants	29.9 years STANDARD_DEVIATION 7.8 • n=7 Participants	31.1 years STANDARD_DEVIATION 8.6 • n=5 Participants	27.4 years STANDARD_DEVIATION 6.1 • n=4 Participants	30.1 years STANDARD_DEVIATION 7.7 • n=21 Participants	27.4 years STANDARD_DEVIATION 6.3 • n=10 Participants	28.5 years STANDARD_DEVIATION 6.8 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	1 Participants n=10 Participants	21 Participants n=115 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	11 Participants n=21 Participants	16 Participants n=10 Participants	59 Participants n=115 Participants
Region of Enrollment United States	15 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	14 participants n=4 Participants	18 participants n=21 Participants	17 participants n=10 Participants	80 participants n=115 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Period 1 Alcohol-placebo n=23 Participants fruit juice	Period 1 Alcohol n=23 Participants Alcohol	Period 3 VI-0521-placebo placebo	Period 3 VI-0521 phentermine/topiramate
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. Breath Alcohol Level 0.10%	1.57 scores on a scale Standard Error 0.06	1.90 scores on a scale Standard Error 0.06	—	—
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. Breath Alcohol Level 0.07%	1.67 scores on a scale Standard Error 0.04	1.88 scores on a scale Standard Error 0.05	—	—
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. Breath Alcohol Level 0.04%	1.62 scores on a scale Standard Error 0.05	1.68 scores on a scale Standard Error 0.05	—	—

PRIMARY outcome

Timeframe: Hour 2 and Hour 6

Population: 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.

Outcome measures

Outcome measures
Measure	Period 1 Alcohol-placebo n=36 Participants fruit juice	Period 1 Alcohol n=36 Participants Alcohol	Period 3 VI-0521-placebo n=36 Participants placebo	Period 3 VI-0521 n=36 Participants phentermine/topiramate
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. Hour 2	1.69 scores on a scale Standard Error 0.04	1.64 scores on a scale Standard Error 0.04	1.65 scores on a scale Standard Error 0.04	1.64 scores on a scale Standard Error 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. Hour 6	1.67 scores on a scale Standard Error 0.04	1.60 scores on a scale Standard Error 0.04	1.65 scores on a scale Standard Error 0.03	1.60 scores on a scale Standard Error 0.03

Adverse Events

Period 1 Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Period 1 Alcohol

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Period 2 and 3 Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Period 2 and 3 Qnexa

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Period 1 Placebo n=39 participants at risk	Period 1 Alcohol n=41 participants at risk	Period 2 and 3 Placebo n=42 participants at risk Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population.	Period 2 and 3 Qnexa n=39 participants at risk The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population.
Gastrointestinal disorders diarrhea	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.9% 2/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.4% 1/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.6% 1/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders dry mouth	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.4% 1/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 2/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	10.3% 4/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders nausea	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	19.5% 8/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Gastrointestinal disorders dyspepsia	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
General disorders pain	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.9% 2/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders disturbance in attention	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders headache	7.7% 3/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	26.8% 11/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	10.3% 4/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Nervous system disorders parethesia	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.8% 2/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	10.3% 4/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	4.9% 2/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.4% 1/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Respiratory, thoracic and mediastinal disorders hiccups	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	7.3% 3/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Respiratory, thoracic and mediastinal disorders pharyngolaryngeal pain	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	9.8% 4/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.4% 1/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Respiratory, thoracic and mediastinal disorders rhinorrhea	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	7.1% 3/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	2.6% 1/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Respiratory, thoracic and mediastinal disorders sinus congestion	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	7.1% 3/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.
Skin and subcutaneous tissue disorders rash	0.00% 0/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/41 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	0.00% 0/42 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.	5.1% 2/39 • AEs were collected from when written informed consent was provided through 28 days after the last dose of investigational product.

Additional Information

Wesley W Day, PhD

Vivus, Inc.

Phone: 650-934-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After Sponsor's written notification that publication of results is no longer planned or 12 months after termination of the study at all sites, Institution \& PI may publish, upon written approval from Sponsor, results of the Study. Sponsor will be given the opportunity to review any proposed publication at least 60 days prior to submission for publication or disclosure. Upon Sponsor's written request, Institution and PI shall not publish or disclose information related to the Study.
Publication restrictions are in place

Restriction type: OTHER