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Trial Outcomes & Findings for Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients (NCT NCT01489969)

NCT ID: NCT01489969

Last Updated: 2018-06-06

Results Overview

The primary efficacy parameter is Latency to persistent sleep (LPS) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period. LPS was summarized at baseline and after two days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the two days was compared, adjusting for the baselinescore. An ANCOVA model was used. Lower score indicates reduction in latency to persistent sleep and thus considered improvement

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

137 participants

Primary outcome timeframe

2 days

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure
Neu-P11 20mg
Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Neu-P11 50mg
Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Placebo
matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Overall Study
STARTED
45
47
45
Overall Study
COMPLETED
40
43
44
Overall Study
NOT COMPLETED
5
4
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Neu-P11 20mg
n=45 Participants
Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Neu-P11 50mg
n=47 Participants
Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Placebo
n=45 Participants
matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Total
n=137 Participants
Total of all reporting groups
Age, Continuous
50.4 years
STANDARD_DEVIATION 16.16 • n=5 Participants
47.4 years
STANDARD_DEVIATION 13.7 • n=7 Participants
51.1 years
STANDARD_DEVIATION 14.52 • n=5 Participants
49.6 years
STANDARD_DEVIATION 14.8 • n=4 Participants
Sex: Female, Male
Female
28 Participants
n=5 Participants
36 Participants
n=7 Participants
33 Participants
n=5 Participants
97 Participants
n=4 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
11 Participants
n=7 Participants
12 Participants
n=5 Participants
40 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
n=5 Participants
13 Participants
n=7 Participants
12 Participants
n=5 Participants
39 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants
n=5 Participants
34 Participants
n=7 Participants
33 Participants
n=5 Participants
98 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=5 Participants
12 Participants
n=7 Participants
11 Participants
n=5 Participants
37 Participants
n=4 Participants
Race (NIH/OMB)
White
31 Participants
n=5 Participants
35 Participants
n=7 Participants
32 Participants
n=5 Participants
98 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 2 days

The primary efficacy parameter is Latency to persistent sleep (LPS) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period. LPS was summarized at baseline and after two days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the two days was compared, adjusting for the baselinescore. An ANCOVA model was used. Lower score indicates reduction in latency to persistent sleep and thus considered improvement

Outcome measures

Outcome measures
Measure
Neu-P11 20mg
n=45 Participants
Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Neu-P11 50mg
n=47 Participants
Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Placebo
n=45 Participants
matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Latency to Persistent Sleep
-22.7 minutes
Standard Deviation 27.39
-39.1 minutes
Standard Deviation 36.53
-37.5 minutes
Standard Deviation 38.43

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

The secondary efficacy parameter is number of awakenings (NOA) measured by the PSG after 28 nights of the double blind treatment period. NOA was summarized at baseline and after 28 days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the 28 nights was compared, adjusting for the baseline score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement.

Outcome measures

Outcome measures
Measure
Neu-P11 20mg
n=41 Participants
Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Neu-P11 50mg
n=43 Participants
Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Placebo
n=44 Participants
matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Number of Awakenings (NOA)
-3.1 Awekenings
Standard Deviation 10.16
-0.1 Awekenings
Standard Deviation 10.28
0.5 Awekenings
Standard Deviation 10.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

The secondary efficacy parameter is the duration of wake after sleep onset (WASO) measured by the PSG after 28 nights of the double blind treatment period. WASO was summarized at baseline and after 28 days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the 28 nights was compared, adjusting for the baseline score. An ANCOVA model was used. Lower score indicates less waking time and thus considered improvement.

Outcome measures

Outcome measures
Measure
Neu-P11 20mg
n=41 Participants
Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Neu-P11 50mg
n=43 Participants
Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Placebo
n=44 Participants
matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Duration of Wake After Sleep Onset (WASO)
-28.1 minutes
Standard Deviation 42.04
-36.1 minutes
Standard Deviation 64.12
-13.3 minutes
Standard Deviation 46.23

Adverse Events

Neu-P11 20mg

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Neu-P11 50mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Neu-P11 20mg
n=45 participants at risk
Neu-P11 dose of 20 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Neu-P11 50mg
n=47 participants at risk
Neu-P11 dose of 50 mg Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Placebo
n=45 participants at risk
matching placebo Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment
Eye disorders
Vision blurred
2.2%
1/45 • Number of events 1 • 28 days
0.00%
0/47 • 28 days
0.00%
0/45 • 28 days
General disorders
Influenza like illness
0.00%
0/45 • 28 days
2.1%
1/47 • Number of events 1 • 28 days
0.00%
0/45 • 28 days
Infections and infestations
Pharyngitis streptococcal
2.2%
1/45 • Number of events 1 • 28 days
0.00%
0/47 • 28 days
0.00%
0/45 • 28 days
Infections and infestations
Scarlet fever
0.00%
0/45 • 28 days
2.1%
1/47 • Number of events 1 • 28 days
0.00%
0/45 • 28 days
Infections and infestations
Upper respiratory tract infection
2.2%
1/45 • Number of events 1 • 28 days
0.00%
0/47 • 28 days
0.00%
0/45 • 28 days
Injury, poisoning and procedural complications
Laceration
2.2%
1/45 • Number of events 1 • 28 days
0.00%
0/47 • 28 days
0.00%
0/45 • 28 days
Metabolism and nutrition disorders
Hyperglycaemia
2.2%
1/45 • Number of events 1 • 28 days
0.00%
0/47 • 28 days
0.00%
0/45 • 28 days
Nervous system disorders
Headache
4.4%
2/45 • Number of events 2 • 28 days
2.1%
1/47 • Number of events 1 • 28 days
0.00%
0/45 • 28 days
Renal and urinary disorders
Haematuria
2.2%
1/45 • Number of events 1 • 28 days
0.00%
0/47 • 28 days
0.00%
0/45 • 28 days

Additional Information

Amnon Katz

Neurim Pharmaceuticals (1991) LTD

Phone: 972-3-768-4906

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60