A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Term Insomnia
Sponsor study identifier
interventional
39
0 countries
N/A
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who do not have chronic insomnia. The study involves 3 one-night stays in a sleep center in New York City.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2016
Actual (reported)February 2016
Date type not reportedThis date has not been verified as actual or estimated.
February 2, 2016
Actual (reported)June 2016
Actual (reported)June 2016
Actual (reported)March 6, 2018
Actual (reported)Total Sleep Time
8 hours
Latency to Persistent Sleep
8 hours
Awakenings
8 hours
Latency to REM Sleep Onset
8 hours
Adverse Events
8 hours
Safety and Tolerability in Terms of Residual Sleepiness
8 hours
SM-1
2-drug combination
Placebo
3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam
2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam
Dahl T, Chen LB, Zammit G, Ahmad M, Roth T. Efficacy of SM-1 in a transient insomnia model. Hum Psychopharmacol. 2019 Nov;34(6):e2713. doi: 10.1002/hup.2713.
Thomas Dahl, PhD
Sequential Medicine Ltd
Maha Ahamad, MD
Clinilabs, Inc.
39 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2016
First Posted
February 2, 2016
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
Placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
March 6, 2018
Results First Posted
March 6, 2018
Record last verified: 2018-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: