Trial Outcomes & Findings for VEC-162 Study in Adult Patients With Primary Insomnia (NCT NCT00548340)

Results Overview

Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

322 participants

Primary outcome timeframe

Baseline, Night 1, and Night 8 measurement

Results posted on

2014-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	VEC-162 20 mg VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo Placebo: Placebo capsules, PO daily for five weeks
Overall Study STARTED	109	109	104
Overall Study COMPLETED	101	98	95
Overall Study NOT COMPLETED	8	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	VEC-162 20 mg VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo Placebo: Placebo capsules, PO daily for five weeks
Overall Study Protocol Violation	2	3	3
Overall Study Adverse Event	2	2	2
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	2	4	3
Overall Study Other	1	1	1

Baseline Characteristics

VEC-162 Study in Adult Patients With Primary Insomnia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VEC-162 20 mg n=109 Participants VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 Participants VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=104 Participants Placebo: Placebo capsules, PO daily for five weeks	Total n=322 Participants Total of all reporting groups
Age, Continuous	42.9 years STANDARD_DEVIATION 10.6 • n=39 Participants	40.7 years STANDARD_DEVIATION 10.4 • n=41 Participants	41.7 years STANDARD_DEVIATION 11.8 • n=35 Participants	41.8 years STANDARD_DEVIATION 10.9 • n=31 Participants
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=39 Participants	109 Participants n=41 Participants	104 Participants n=35 Participants	322 Participants n=31 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants
Sex: Female, Male Female	66 Participants n=39 Participants	63 Participants n=41 Participants	68 Participants n=35 Participants	197 Participants n=31 Participants
Sex: Female, Male Male	43 Participants n=39 Participants	46 Participants n=41 Participants	36 Participants n=35 Participants	125 Participants n=31 Participants

PRIMARY outcome

Timeframe: Baseline, Night 1, and Night 8 measurement

Population: One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.

Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8.

Outcome measures

Outcome measures
Measure	VEC-162 20 mg n=108 Participants VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 Participants VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=104 Participants Placebo: Placebo capsules, PO daily for five weeks
Average Change From Baseline - Latency to Persistent Sleep (LPS)	45.0 minutes Standard Error 2.965	46.4 minutes Standard Error 2.954	28.3 minutes Standard Error 3.020

SECONDARY outcome

Timeframe: Baseline, Night 1, and Night 8 measurements for WASO and TST

Population: One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.

Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8.

Outcome measures

Outcome measures
Measure	VEC-162 20 mg n=108 Participants VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 Participants VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=104 Participants Placebo: Placebo capsules, PO daily for five weeks
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) Avg TST Change from Baseline	51.4 minutes Standard Error 4.794	52.0 minutes Standard Error 4.775	39.9 minutes Standard Error 4.882
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) Avg WASO Change from Baseline	12.2 minutes Standard Error 4.349	14.1 minutes Standard Error 4.329	11.7 minutes Standard Error 4.569

POST_HOC outcome

Timeframe: Baseline, Night 22, and Night 29 measurement

Population: One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.

Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline, and the average of nights 22 and 29.

Outcome measures

Outcome measures
Measure	VEC-162 20 mg n=108 Participants VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 Participants VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=104 Participants Placebo: Placebo capsules, PO daily for five weeks
Average Change From Baseline - Latency to Persistent Sleep (LPS)	49.4 minutes Standard Error 3.309	45.1 minutes Standard Error 3.292	33.9 minutes Standard Error 3.338

POST_HOC outcome

Timeframe: Baseline, Night 22, and Night 29 measurements for WASO and TST

Population: One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.

Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 22 and 29. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 22 and 29.

Outcome measures

Outcome measures
Measure	VEC-162 20 mg n=108 Participants VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 Participants VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=104 Participants Placebo: Placebo capsules, PO daily for five weeks
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) Avg WASO Change from Baseline	17.7 minutes Standard Error 4.139	10.2 minutes Standard Error 4.184	20.3 minutes Standard Error 4.381
Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) Avg TST Change from Baseline	60.3 minutes Standard Error 4.821	48.6 minutes Standard Error 4.802	47.4 minutes Standard Error 4.882

Adverse Events

VEC-162 20 mg

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

VEC-162 50 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	VEC-162 20 mg n=109 participants at risk VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 participants at risk VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=109 participants at risk；n=104 participants at risk Placebo: Placebo capsules, PO daily for five weeks
Vascular disorders Hypertensive Emergency	0.00% 0/109 • Night 1 to Day 37 (EOS)	0.00% 0/109 • Night 1 to Day 37 (EOS)	0.96% 1/104 • Number of events 1 • Night 1 to Day 37 (EOS)
Investigations Blood Pressure Increased	0.92% 1/109 • Number of events 1 • Night 1 to Day 37 (EOS)	0.00% 0/109 • Night 1 to Day 37 (EOS)	0.00% 0/104 • Night 1 to Day 37 (EOS)

Other adverse events

Other adverse events
Measure	VEC-162 20 mg n=109 participants at risk VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks	VEC-162 50 mg n=109 participants at risk VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks	Placebo n=109 participants at risk；n=104 participants at risk Placebo: Placebo capsules, PO daily for five weeks
Nervous system disorders Headache	10.1% 11/109 • Number of events 14 • Night 1 to Day 37 (EOS)	3.7% 4/109 • Number of events 4 • Night 1 to Day 37 (EOS)	4.6% 5/109 • Number of events 6 • Night 1 to Day 37 (EOS)
Infections and infestations Nasopharyngitis	2.8% 3/109 • Number of events 3 • Night 1 to Day 37 (EOS)	3.7% 4/109 • Number of events 4 • Night 1 to Day 37 (EOS)	3.7% 4/109 • Number of events 4 • Night 1 to Day 37 (EOS)
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/109 • Night 1 to Day 37 (EOS)	4.6% 5/109 • Number of events 5 • Night 1 to Day 37 (EOS)	1.8% 2/109 • Number of events 2 • Night 1 to Day 37 (EOS)
Infections and infestations Urinary Tract Infection	3.7% 4/109 • Number of events 4 • Night 1 to Day 37 (EOS)	1.8% 2/109 • Number of events 2 • Night 1 to Day 37 (EOS)	0.92% 1/109 • Number of events 1 • Night 1 to Day 37 (EOS)

Additional Information

Marlene Dressman, Ph.D.

Vanda Pharmaceuticals Inc.

Phone: 202-734-3462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place