An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia

Study Description

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Brief Summary:

The purpose of this study is to assess the efficacy and pattern of use of the combination drug product SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or placebo to take at home as needed over the course of 3 months treatment period.

Condition or disease	Intervention/treatment	Phase
Transient Insomnia	Drug: SM-1; Drug: Placebo	Phase 3

Detailed Description:

The purpose of this study is to assess the efficacy, safety, tolerability and pattern of use of SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. SM-1 is a combination drug product containing diphenhydramine, zolpidem and lorazepam. The study is a parallel group design; participants will receive either SM-1 or placebo to take at home as needed over the course of 3 months treatment period.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	220 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Double-Blind, Placebo-Controlled, Parallel Design Phase 3 Study to Assess the Efficacy, Safety, Tolerability, and Pattern of Use of SM-1 in Adult Subjects With a History of Transient Insomnia
Estimated Study Start Date :	March 2018
Estimated Primary Completion Date :	January 2019
Estimated Study Completion Date :	January 2019

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Experimental (SM-1); Drug: SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.	Drug: SM-1; SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam self-administered as needed to promote sleep
Placebo Comparator: Placebo; Drug: Placebo Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials.	Drug: Placebo; Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials, self-administered as needed to promote sleep

Outcome Measures

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Primary Outcome Measures :

1. Subjective Total Sleep Time [ Time Frame: 7 nights ]
   Total time spent sleeping each night as reported by the subject

Secondary Outcome Measures :

1. Pattern of use [ Time Frame: 3 months ]
   Subject reported total number of uses and consecutive nights of use
2. Safety Adverse Events [ Time Frame: Through study completion, 17 weeks ]
   Adverse Events
3. Safety Residual Effects [ Time Frame: Through study completion, 17 weeks ]
   Subject reported answer to the Question, "How alert or sleepy do you feel this morning?" Subjects will rate their alertness on a scale from 0 to 5, with 0 being extremely sleepy and 5 being extremely alert
4. Safety Rebound Insomnia [ Time Frame: Through study completion, 17 weeks ]
   Total time spent sleeping each night as reported by the subject on night after taking drug or night after not taking drug

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Experienced at least 1 prior episode of transient insomnia meeting all of the following criteria: difficulty falling asleep or staying asleep; next day impairment or distress associated with the disturbed sleep; frequency of 1 to 7 nights per week; duration of less than 1 month or more than 1 month of intermittent episodes.
• Routinely spends 6.5 - 9.5 hours in bed each night, with bed time varying no more than 2 hours over a week.
• Body Mass Index (BMI) between 19 and 32 kg/m2.
• Good general health, as determined by a thorough medical, sleep and psychiatric history review, brief physical examination including vital sign measurements, and an assessment of screening laboratory test results.
• Agrees, for the duration of the study, to take only study drug to address difficulty falling asleep or staying asleep, and to not drink alcohol within 2 hours of expected bedtime.

Exclusion Criteria:

• Females who are pregnant, breast-feeding, or planning a pregnancy during the study period.
• Clinically significant medical disorder or currently unstable medical condition that, in the opinion of the investigator, would confound the results of the study.
• Abnormal laboratory value at screening, judged clinically significant by the investigator.
• History or current evidence of severe hepatic (liver) impairment.
• Clinically significant psychiatric illness, or the history or presence of a major psychiatric illness in the past year.
• Has a significant risk (in the opinion of the investigator) for suicidal behavior during the course of participation in the study or a) At screening: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to screening; or b) At screening: the subject has had one or more suicidal attempts within a 2-year period prior to screening; or c) At the baseline visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to screening; or d) The subject is considered to be an imminent danger to self or others.
• Has a history of chronic insomnia or other sleep disorders, such as sleep apnea, narcolepsy, parasomnia, restless leg syndrome, or circadian rhythm disorder.
• Has used medications to aid sleep on most nights during the past 2 months.
• Has a history of night work or shift work within the month prior to screening or a need to participate in night work or shift work during the study.
• Has a history of alcohol or substance use disorder within the year prior to screening, or current evidence of alcohol or substance use disorder as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 5th Edition.
• Self-report of a usual consumption of more than 14 units of alcohol per week: 1 unit of alcohol is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of liquor.
• Has a history of routinely smoking during sleep period.
• Has discontinued smoking or participated in a smoking cessation program within 28 days of screening, or plans to discontinue smoking during the study.
• Has used within 2 weeks or 5 half-lives (whichever is longer) prior to screening of any medication that affects sleep-wake function.
• Has a positive urine drug screen at the screening visit.
• Has a history of allergy or known sensitivity, hypersensitivity, or adverse reaction to diphenhydramine, zolpidem, lorazepam, or related compounds.
• Has had treatment with any other investigational drug within 28 days or 5 half-lives (whichever is longer) prior to screening.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Christy Beaudoin-Parker	910-558-3628	Christy.Beaudoin-Parker@ppdi.com

Sponsors and Collaborators

Sequential Medicine Ltd

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sequential Medicine Ltd
ClinicalTrials.gov Identifier:	NCT03338764 History of Changes
Other Study ID Numbers:	SM-A-06
First Posted:	November 9, 2017
Last Update Posted:	November 9, 2017
Last Verified:	November 2017

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Sequential Medicine Ltd:

Transient insomnia; Insomnia; Sleep initiation and maintenance disorder

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Diphenhydramine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents	Peripheral Nervous System Agents; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hypnotics and Sedatives; Anti-Allergic Agents