VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

• Sponsor: Vanda Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00291187
• Collaborator: (none)
• Enrollment: 411
• Locations: 19
• Arms: 4
• Duration (Months): 5.9
• Patients Per Site: 21.6
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: 20 mg VEC-162; Drug: 50 mg VEC-162; Drug: 100 mg VEC-162; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 411 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia
• Study Start Date: Feb 1, 2006
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Take orally 30 minutes prior to bedtime.	Drug: Placebo; Placebo
Experimental: 20 mg VEC-162 20 mg taken orally 30 minutes prior to bedtime.	Drug: 20 mg VEC-162; 20 mg VEC-162
Experimental: 50 mg VEC-162 50 mg taken orally 30 minutes prior to bedtime.	Drug: 50 mg VEC-162; 50 mg VEC-162
Experimental: 100 mg VEC-162 100 mg taken orally 30 minutes prior to bedtime.	Drug: 100 mg VEC-162; 100 mg VEC-162

Outcome Measures

Primary Outcome Measures

1. Average Improvement of Latency to Persistent Sleep (LPS) [Night 1]

   The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.

Secondary Outcome Measures

1. Average Improvement of Wake After Sleep Onset (WASO) [Night 1]

   The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy subjects with no medical, psychiatric or current sleep disorders.

• Subject must sign a written consent form.

Exclusion Criteria:

• Recent history of night shift work or jet lag.

• Prior experience sleeping in a sleep lab environment.

• History of sleep disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanda Investigational Site	Birmingham	Alabama	United States
2	Vanda Investigational Site	Phoenix	Arizona	United States
3	Vanda Investigational Site	San Diego	California	United States
4	Vanda Investigational Site	San Francisco	California	United States
5	Vanda Investigational Site	Santa Monica	California	United States
6	Vanda Investigational Site	Miami	Florida	United States
7	Vanda Investigational Site	Naples	Florida	United States
8	Vanda Investigational Site	Pembroke Pines	Florida	United States
9	Vanda Investigational Site	St. Petersburg	Florida	United States
10	Vanda Investigational Site	Atlanta	Georgia	United States
11	Vanda Investigational Site	Overland Park	Kansas	United States
12	Vanda Investigational Site	Chevy Chase	Maryland	United States
13	Vanda Investigational Site	New York	New York	United States
14	Vanda Investigational Site	Rochester	New York	United States
15	Vanda Investigational Site	Raleigh	North Carolina	United States
16	Vanda Investigational Site	Cincinnati	Ohio	United States
17	Vanda Investigational Site	Columbia	South Carolina	United States
18	Vanda Investigational Site	Austin	Texas	United States
19	Vanda Investigational Site	Plano	Texas	United States

Sponsors and Collaborators

• Vanda Pharmaceuticals

Investigators

• Study Director: Vanda Pharmaceuticals, Vanda Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00291187
• Other Study ID Numbers: VP-VEC-162-3101
• First Posted: Feb 13, 2006
• Last Update Posted: Oct 15, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Recruitment Details	Recruitment took place at 20 US sites. The first subject was screened on February 9th 2006, the first subject enrolled on March 10th, 2006, and the last subject completed on August 21st 2006.
Pre-assignment Detail	Prior to treatment assignment, subjects were instructed to start a sleep schedule that required staying in bed and trying to sleep for at least 8 hours per night. One subject randomized to VEC-162 50 mg was non-compliant for sleep schedule. Subject was discontinued on Day 1 prior to study drug administration.

Arm/Group Title	Placebo	VEC-162 20 mg	VEC-162 50 mg	VEC-162 100 mg
Arm/Group Description	taken orally 30 minutes prior to bedtime	20 mg taken orally 30 minutes prior to bedtime	50 mg taken orally 30 minutes prior to bedtime	100 mg taken orally 30 minutes prior to bedtime
Period Title: Overall Study
STARTED	103	100	103	106
COMPLETED	103	100	102	106
NOT COMPLETED	0	0	1	0

Baseline Characteristics

Arm/Group Title	Placebo	VEC-162 20 mg	VEC-162 50 mg	VEC-162 100 mg	Total
Arm/Group Description	Taken orally 30 minutes prior to bedtime.	20 mg taken orally 30 minutes prior to bedtime.	50 mg taken orally 30 minutes prior to bedtime.	100 mg taken orally 30 minutes prior to bedtime.	Total of all reporting groups
Overall Participants	103	100	102	106	411
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.9 (7.28)	30.8 (8.41)	31.0 (8.51)	31.2 (8.19)	31.0 (8.08)
Sex: Female, Male (Count of Participants)
Female	68 66%	62 62%	58 56.9%	73 68.9%	261 63.5%
Male	35 34%	38 38%	44 43.1%	33 31.1%	150 36.5%

Outcome Measures

1. Primary Outcome

Title	Average Improvement of Latency to Persistent Sleep (LPS)
Description	The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Time Frame	Night 1

Outcome Measure Data

Analysis Population Description

Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.

Arm/Group Title	Placebo	VEC-162 20 mg	VEC-162 50 mg	VEC-162 100 mg
Arm/Group Description	Taken orally 30 minutes prior to bedtime.	20 mg taken orally 30 minutes prior to bedtime.	50 mg taken orally 30 minutes prior to bedtime.	100 mg taken orally 30 minutes prior to bedtime.
Measure Participants	103	100	102	106
Mean (Standard Error) [minutes]	45.8 (4.28)	24.3 (4.35)	19.6 (4.31)	23.1 (4.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 20 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-21.5
	Confidence Interval	(2-Sided) 95%; -33.1 to -9.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 50 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-26.3
	Confidence Interval	(2-Sided) 95%; -37.8 to -14.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 100 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-22.8
	Confidence Interval	(2-Sided) 95%; -34.2 to -11.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Average Improvement of Wake After Sleep Onset (WASO)
Description	The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Time Frame	Night 1

Outcome Measure Data

Analysis Population Description

Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.

Arm/Group Title	Placebo	VEC-162 20 mg	VEC-162 50 mg	VEC-162 100 mg
Arm/Group Description	Taken orally 30 minutes prior to bedtime.	20 mg taken orally 30 minutes prior to bedtime	50 mg taken orally 30 minutes prior to bedtime	100 mg taken orally 30 minutes prior to bedtime
Measure Participants	103	100	102	106
Mean (Standard Error) [minutes]	139.3 (7.33)	115.1 (7.46)	105.6 (7.39)	121.9 (7.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 20 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-24.2
	Confidence Interval	(2-Sided) 95%; -44.1 to -4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 50 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.7
	Confidence Interval	(2-Sided) 95%; -53.6 to -13.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 100 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.081
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-17.4
	Confidence Interval	(2-Sided) 95%; -37.0 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Post-Hoc Outcome

Title	Average Improvement in Total Sleep Time (TST)
Description	The average improvement in Total sleep time (determined by PSG and defined as the number of non-wake minutes between lights off and lights on) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Time Frame	Night 1

Outcome Measure Data

Analysis Population Description

Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.

Arm/Group Title	Placebo	VEC-162 20 mg	VEC-162 50 mg	VEC-162 100 mg
Arm/Group Description	Taken orally 30 minutes prior to bedtime.	20 mg taken orally 30 minutes prior to bedtime.	50 mg taken orally 30 minutes prior to bedtime.	100 mg taken orally 30 minutes prior to bedtime.
Measure Participants	103	100	102	106
Mean (Standard Error) [Minutes]	317.6 (7.65)	351.4 (7.78)	365.5 (7.71)	347.2 (7.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 20 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	33.7
	Confidence Interval	(2-Sided) 95%; 13.0 to 54.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 50 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	47.9
	Confidence Interval	(2-Sided) 95%; 27.2 to 68.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 100 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	29.6
	Confidence Interval	(2-Sided) 95%; 9.1 to 50.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Post-Hoc Outcome

Title	Average Improvement in Latency to Non-awake (LNA)
Description	The average improvement in latency to non-awake (length of time elapsed between lights off and first epoch of sleep determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects.
Time Frame	Night 1

Outcome Measure Data

Analysis Population Description

Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored.

Arm/Group Title	Placebo	VEC-162 20 mg	VEC-162 50 mg	VEC-162 100 mg
Arm/Group Description	Taken orally 30 minutes prior to bedtime	20 mg taken orally 30 minutes prior to bedtime.	50 mg taken orally 30 minutes prior to bedtime.	100 mg taken orally 30 minutes prior to bedtime.
Measure Participants	103	100	102	106
Mean (Standard Error) [Minutes]	22.3 (2.88)	11.2 (2.93)	8.0 (2.90)	10.0 (2.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 20 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.1
	Confidence Interval	(2-Sided) 95%; -18.9 to -3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 50 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-14.3
	Confidence Interval	(2-Sided) 95%; -22.1 to -6.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, VEC-162 100 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.3
	Confidence Interval	(2-Sided) 95%; -20.0 to -4.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Day 1 through Day 2.
Arm/Group Title	Placebo		VEC-162 20 mg		VEC-162 50 mg		VEC-162 100 mg
Arm/Group Description	Taken orally 30 minutes prior to bedtime.		20 mg taken orally 30 minutes prior to bedtime.		50 mg taken orally 30 minutes prior to bedtime.		100 mg taken orally 30 minutes prior to bedtime.
All Cause Mortality
	Placebo		VEC-162 20 mg		VEC-162 50 mg		VEC-162 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		VEC-162 20 mg		VEC-162 50 mg		VEC-162 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/103 (0%)		0/100 (0%)		0/102 (0%)		0/106 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		VEC-162 20 mg		VEC-162 50 mg		VEC-162 100 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/103 (4.9%)		7/100 (7%)		5/102 (4.9%)		6/106 (5.7%)
Gastrointestinal disorders
Nausea	3/103 (2.9%)	3	3/100 (3%)	3	3/102 (2.9%)	3	3/106 (2.8%)	3
Dry Mouth	0/103 (0%)	0	2/100 (2%)	2	1/102 (1%)	1	0/106 (0%)	0
Dyspepsia	0/103 (0%)	0	0/100 (0%)	0	1/102 (1%)	1	2/106 (1.9%)	2
Nervous system disorders
Headache	3/103 (2.9%)	3	0/100 (0%)	0	1/102 (1%)	1	1/106 (0.9%)	1
Psychiatric disorders
Abnormal Dreams	0/103 (0%)	0	1/100 (1%)	1	2/102 (2%)	3	1/106 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Dry Throat	0/103 (0%)	0	2/100 (2%)	2	0/102 (0%)	0	1/106 (0.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.