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

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ClinicalTrials.gov Identifier: NCT01489969
Recruitment Status : Completed
First Posted : December 12, 2011
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Neurim Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Primary Insomnia
Intervention Drug: Neu-P11
Enrollment 137

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neu-P11 20mg Neu-P11 50mg Placebo
Hide Arm/Group Description

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 dose of 50 mg

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

matching placebo

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Period Title: Overall Study
Started 45 47 45
Completed 40 43 44
Not Completed 5 4 1
Arm/Group Title Neu-P11 20mg Neu-P11 50mg Placebo Total
Hide Arm/Group Description

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 dose of 50 mg

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

matching placebo

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Total of all reporting groups
Overall Number of Baseline Participants 45 47 45 137
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 47 participants 45 participants 137 participants
50.4  (16.16) 47.4  (13.7) 51.1  (14.52) 49.6  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 45 participants 137 participants
Female
28
  62.2%
36
  76.6%
33
  73.3%
97
  70.8%
Male
17
  37.8%
11
  23.4%
12
  26.7%
40
  29.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 45 participants 137 participants
Hispanic or Latino
14
  31.1%
13
  27.7%
12
  26.7%
39
  28.5%
Not Hispanic or Latino
31
  68.9%
34
  72.3%
33
  73.3%
98
  71.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 47 participants 45 participants 137 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
2
   4.4%
2
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  31.1%
12
  25.5%
11
  24.4%
37
  27.0%
White
31
  68.9%
35
  74.5%
32
  71.1%
98
  71.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Latency to Persistent Sleep
Hide Description 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
Time Frame 2 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neu-P11 20mg Neu-P11 50mg Placebo
Hide Arm/Group Description:

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 dose of 50 mg

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

matching placebo

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Overall Number of Participants Analyzed 45 47 45
Mean (Standard Deviation)
Unit of Measure: minutes
-22.7  (27.39) -39.1  (36.53) -37.5  (38.43)
2.Other Pre-specified Outcome
Title Number of Awakenings (NOA)
Hide Description 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.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neu-P11 20mg Neu-P11 50mg Placebo
Hide Arm/Group Description:

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 dose of 50 mg

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

matching placebo

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Overall Number of Participants Analyzed 41 43 44
Mean (Standard Deviation)
Unit of Measure: Awekenings
-3.1  (10.16) -0.1  (10.28) 0.5  (10.26)
3.Other Pre-specified Outcome
Title Duration of Wake After Sleep Onset (WASO)
Hide Description 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.
Time Frame 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neu-P11 20mg Neu-P11 50mg Placebo
Hide Arm/Group Description:

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 dose of 50 mg

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

matching placebo

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Overall Number of Participants Analyzed 41 43 44
Mean (Standard Deviation)
Unit of Measure: minutes
-28.1  (42.04) -36.1  (64.12) -13.3  (46.23)
Time Frame 28 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neu-P11 20mg Neu-P11 50mg Placebo
Hide Arm/Group Description

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 dose of 50 mg

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

matching placebo

Neu-P11: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

All-Cause Mortality
Neu-P11 20mg Neu-P11 50mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)      0/47 (0.00%)      0/45 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Neu-P11 20mg Neu-P11 50mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/45 (0.00%)      0/47 (0.00%)      0/45 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Neu-P11 20mg Neu-P11 50mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/45 (17.78%)      3/47 (6.38%)      0/45 (0.00%)    
Eye disorders       
Vision blurred   1/45 (2.22%)  1 0/47 (0.00%)  0 0/45 (0.00%)  0
General disorders       
Influenza like illness   0/45 (0.00%)  0 1/47 (2.13%)  1 0/45 (0.00%)  0
Infections and infestations       
Pharyngitis streptococcal   1/45 (2.22%)  1 0/47 (0.00%)  0 0/45 (0.00%)  0
Scarlet fever   0/45 (0.00%)  0 1/47 (2.13%)  1 0/45 (0.00%)  0
Upper respiratory tract infection   1/45 (2.22%)  1 0/47 (0.00%)  0 0/45 (0.00%)  0
Injury, poisoning and procedural complications       
Laceration   1/45 (2.22%)  1 0/47 (0.00%)  0 0/45 (0.00%)  0
Metabolism and nutrition disorders       
Hyperglycaemia   1/45 (2.22%)  1 0/47 (0.00%)  0 0/45 (0.00%)  0
Nervous system disorders       
Headache   2/45 (4.44%)  2 1/47 (2.13%)  1 0/45 (0.00%)  0
Renal and urinary disorders       
Haematuria   1/45 (2.22%)  1 0/47 (0.00%)  0 0/45 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Results Point of Contact
Name/Title: Amnon Katz
Organization: Neurim Pharmaceuticals (1991) LTD
Phone: 972-3-768-4906
Responsible Party: Neurim Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01489969     History of Changes
Other Study ID Numbers: Neu-P11-03-PSG
First Submitted: December 6, 2011
First Posted: December 12, 2011
Results First Submitted: March 29, 2018
Results First Posted: June 6, 2018
Last Update Posted: June 6, 2018