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Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia

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ClinicalTrials.gov Identifier: NCT02671760
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Clinilabs, Inc.
Information provided by (Responsible Party):
Sequential Medicine Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Short-term Insomnia
Interventions Drug: SM-1
Drug: Comparator
Drug: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Experimental: SM-1 Then Comparator Then Placebo Experimental: Comparator Then Placebo Then SM-1 Experimental: Placebo Then SM-1 Then Comparator
Hide Arm/Group Description Subjects received a single dose of SM-1 followed by a 5-16 day washout. They the received a single dose of Comparator followed by a 5-16 day washout. They then received a single dose of Placebo. Subjects received a single dose of Comparator followed by a 5-16 day washout. They the received a single dose of Placebo followed by a 5-16 day washout. They then received a single dose of SM-1. Subjects received a single dose of Placebo followed by a 5-16 day washout. They the received a single dose of SM-1 followed by a 5-16 day washout. They then received a single dose of Comparator.
Period Title: Overall Study
Started 13 13 13
Completed 13 12 [1] 13
Not Completed 0 1 0
Reason Not Completed
Lost to Follow-up             0             1             0
[1]
1 Subject could not be contacted for f/u phone call. Data included in safety and efficacy analyses.
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants regardless of randomization sequence.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
41.9  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
13
  33.3%
Male
26
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Hispanic or Latino
11
  28.2%
Not Hispanic or Latino
28
  71.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
American Indian or Alaska Native
0
   0.0%
Asian
5
  12.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
25
  64.1%
White
9
  23.1%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Total Sleep Time
Hide Description [Not Specified]
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: minutes
382.9  (57.95) 339.2  (76.57) 256.2  (98.15)
2.Secondary Outcome
Title Latency to Persistent Sleep
Hide Description Time it takes to fall asleep
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: minutes
31.2  (52.34) 42.1  (52.04) 50.1  (73.13)
3.Secondary Outcome
Title Awakenings
Hide Description [Not Specified]
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: Awakenings
12.2  (6.73) 11.0  (6.61) 9.6  (5.86)
4.Secondary Outcome
Title Latency to REM Sleep Onset
Hide Description Time required to achieve REM sleep
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: minutes
112.5  (53.61) 71.3  (43.89) 61.2  (36.70)
5.Secondary Outcome
Title Adverse Events
Hide Description Safety and tolerability assessed in terms of the incidence of AEs
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Measure Type: Number
Unit of Measure: Number of Events
2 3 2
6.Secondary Outcome
Title Safety and Tolerability in Terms of Residual Sleepiness
Hide Description Karolinska Sleepiness Scale. This is a 9-point scale with values ranging from 1 (extremely alert) to 9 (extremely sleepy). Lower scores indicate less residual sleepiness.
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.8  (2.06) 6.0  (1.80) 6.1  (2.03)
7.Secondary Outcome
Title Safety and Tolerability in Terms of Residual Sleepiness
Hide Description Digit Symbol Substitution Test. The test score is number of correct answers in 90 seconds. Higher scores indicate favorable response (i.e., less residual sleepiness). The duration of the challenge is the 90 second time limit; there is no theoretical maximum score to attain.
Time Frame 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description:

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

Overall Number of Participants Analyzed 39 39 39
Mean (Standard Deviation)
Unit of Measure: Correct answers
53.1  (15.97) 53.3  (13.74) 55.3  (14.07)
Time Frame Entire study, up to 7 days after the last treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Comparator Placebo
Hide Arm/Group Description

SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

2-drug combination

Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Placebo

Placebo: Placebo

All-Cause Mortality
Treatment Comparator Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/39 (0.00%)      0/39 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Comparator Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      0/39 (0.00%)      0/39 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Comparator Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/39 (5.13%)      3/39 (7.69%)      3/39 (7.69%)    
Nervous system disorders       
Headache * 1  0/39 (0.00%)  0 0/39 (0.00%)  0 1/39 (2.56%)  1
Somnolence * 1  1/39 (2.56%)  1 3/39 (7.69%)  3 1/39 (2.56%)  1
Psychiatric disorders       
Initial Insomnia * 1  1/39 (2.56%)  1 0/39 (0.00%)  0 1/39 (2.56%)  1
1
Term from vocabulary, MedDRA 18.1
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Product Development
Organization: Sequential Medicine Ltd
Phone: 617-818-2735
EMail: tadahl@outlook.com
Layout table for additonal information
Responsible Party: Sequential Medicine Ltd
ClinicalTrials.gov Identifier: NCT02671760     History of Changes
Other Study ID Numbers: SM-A-02
First Submitted: January 20, 2016
First Posted: February 2, 2016
Results First Submitted: October 9, 2017
Results First Posted: March 6, 2018
Last Update Posted: March 6, 2018