Trial Outcomes & Findings for Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia (NCT NCT02671760)

NCT ID: NCT02671760

Last Updated: 2018-03-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2018-03-06

Participant Flow

Participant milestones

Measure	Experimental: SM-1 Then Comparator Then Placebo 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.	Experimental: Comparator Then Placebo Then SM-1 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.	Experimental: Placebo Then SM-1 Then Comparator 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.
Overall Study STARTED	13	13	13
Overall Study COMPLETED	13	12	13
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Measure	Experimental: SM-1 Then Comparator Then Placebo 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.	Experimental: Comparator Then Placebo Then SM-1 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.	Experimental: Placebo Then SM-1 Then Comparator 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.
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Study Participants n=39 Participants All study participants regardless of randomization sequence.
Age, Continuous	41.9 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Total Sleep Time	382.9 minutes Standard Deviation 57.95	339.2 minutes Standard Deviation 76.57	256.2 minutes Standard Deviation 98.15

SECONDARY outcome

Timeframe: 8 hours

Time it takes to fall asleep

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Latency to Persistent Sleep	31.2 minutes Standard Deviation 52.34	42.1 minutes Standard Deviation 52.04	50.1 minutes Standard Deviation 73.13

SECONDARY outcome

Timeframe: 8 hours

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Awakenings	12.2 Awakenings Standard Deviation 6.73	11.0 Awakenings Standard Deviation 6.61	9.6 Awakenings Standard Deviation 5.86

SECONDARY outcome

Timeframe: 8 hours

Time required to achieve REM sleep

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Latency to REM Sleep Onset	112.5 minutes Standard Deviation 53.61	71.3 minutes Standard Deviation 43.89	61.2 minutes Standard Deviation 36.70

SECONDARY outcome

Timeframe: 8 hours

Safety and tolerability assessed in terms of the incidence of AEs

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Adverse Events	2 Number of Events	3 Number of Events	2 Number of Events

SECONDARY outcome

Timeframe: 8 hours

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.

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Safety and Tolerability in Terms of Residual Sleepiness	5.8 Units on a scale Standard Deviation 2.06	6.0 Units on a scale Standard Deviation 1.80	6.1 Units on a scale Standard Deviation 2.03

SECONDARY outcome

Timeframe: 8 hours

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.

Outcome measures

Measure	Treatment n=39 Participants SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 Participants 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 Participants Placebo Placebo: Placebo
Safety and Tolerability in Terms of Residual Sleepiness	53.1 Correct answers Standard Deviation 15.97	53.3 Correct answers Standard Deviation 13.74	55.3 Correct answers Standard Deviation 14.07

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Comparator

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=39 participants at risk SM-1 SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam	Comparator n=39 participants at risk 2-drug combination Comparator: 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam	Placebo n=39 participants at risk Placebo Placebo: Placebo
Nervous system disorders Headache	0.00% 0/39 • Entire study, up to 7 days after the last treatment.	0.00% 0/39 • Entire study, up to 7 days after the last treatment.	2.6% 1/39 • Number of events 1 • Entire study, up to 7 days after the last treatment.
Psychiatric disorders Initial Insomnia	2.6% 1/39 • Number of events 1 • Entire study, up to 7 days after the last treatment.	0.00% 0/39 • Entire study, up to 7 days after the last treatment.	2.6% 1/39 • Number of events 1 • Entire study, up to 7 days after the last treatment.
Nervous system disorders Somnolence	2.6% 1/39 • Number of events 1 • Entire study, up to 7 days after the last treatment.	7.7% 3/39 • Number of events 3 • Entire study, up to 7 days after the last treatment.	2.6% 1/39 • Number of events 1 • Entire study, up to 7 days after the last treatment.

Additional Information

Head of Product Development

Sequential Medicine Ltd

Phone: 617-818-2735

Email: tadahl@outlook.com

Results disclosure agreements

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