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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Neu-P11 20mg   Neu-P11 50mg   Placebo
STARTED   45   47   45 
COMPLETED   40   43   44 
NOT COMPLETED   5   4   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Neu-P11 20mg   Neu-P11 50mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   47   45   137 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (16.16)   47.4  (13.7)   51.1  (14.52)   49.6  (14.8) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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% 


  Outcome Measures

1.  Primary:   Latency to Persistent Sleep   [ Time Frame: 2 days ]

2.  Other Pre-specified:   Number of Awakenings (NOA)   [ Time Frame: 28 days ]

3.  Other Pre-specified:   Duration of Wake After Sleep Onset (WASO)   [ Time Frame: 28 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: amnonk@neurim.com



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