SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.

NCT03331042 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SM-A-05
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1, or a combination of diphenhydramine and zolpidem, or a combination of diphenhydramine and lorazepam, or placebo during 4 one-night stays at a sleep center.

Conditions

Transient Insomnia

Keywords

Insomnia; Transient Insomnia; Sleep initiation and maintenance disorder

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time (TST)

  TST efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-defined total sleep time (TST)

  8 hours

Secondary Outcomes (9)

• Latency to Persistent Sleep (LPS)

  8 hours

• Number of Awakenings (NAW)

  8 hours

• Wakefulness After Sleep Onset (WASO)

  8 hours

• Karolinska Sleepiness Scale (KSS) of Morning Alertness.

  Up to Visit 5

• Number Correct on Digit Symbol Substitution Test (DSST)

  Up to Visit 5

Other Outcomes (1)

• Number of Minutes of Sleep in Stages N1, N2, N3, Rapid Eye Movement (REM) and Latency to REM Onset.

  8 hours

Study Arms (4)

Sequence 1

EXPERIMENTAL

SM-1 (Treatment Period 1), D+Z (Treatment Period 2), D+L (Treatment Period 3), Placebo (Treatment Period 4).

Drug: SM-1; Drug: D+Z; Drug: D+L; Drug: Placebo

Sequence 2

EXPERIMENTAL

D+Z (Treatment Period 1), D+L (Treatment Period 2), Placebo (Treatment Period 3), SM-1 (Treatment Period 4).

Drug: SM-1; Drug: D+Z; Drug: D+L; Drug: Placebo

Sequence 3

EXPERIMENTAL

D+L (Treatment Period 1), Placebo (Treatment Period 2), SM-1 (Treatment Period 3), D+Z (Treatment Period 4).

Drug: SM-1; Drug: D+Z; Drug: D+L; Drug: Placebo

Sequence 4

EXPERIMENTAL

Placebo (Treatment Period 1), SM-1 (Treatment Period 2), D+Z (Treatment Period 3), D+L (Treatment Period 4).

Drug: SM-1; Drug: D+Z; Drug: D+L; Drug: Placebo

Interventions

SM-1 DRUG

3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.

Sequence 1; Sequence 2; Sequence 3; Sequence 4

D+Z DRUG

2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.

Sequence 1; Sequence 2; Sequence 3; Sequence 4

D+L DRUG

2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Placebo DRUG

Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written consent form.
• 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. Potential participants will be required to complete a paper diary for a minimum of 7 days during the screening period, with at least 5 entries completed over the 7 days.
• 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.
• Female subjects of childbearing potential must be using an acceptable method of contraception during the study and for the 30 days following the last dose of study drug, and must have a negative urine pregnancy test at every study visit. Female subjects of non-childbearing potential are not required to use contraception if they have been surgically sterilized or are post-menopausal as defined by the cessation of menses for a period of at least 2 years before screening.
• Male subjects must use an acceptable method of contraception during the study and for the 30 days following the last dose of study drug.
• Willing and able to be confined to the study center for 1 night in each of 4 treatment periods, as required by the protocol.
• Refrains from the use of alcohol within 24 hours of check-in for each of 4 treatment periods involving an overnight stay at the study center.
• Refrains from napping (any sleep episode occurring outside subject's main sleep episode) on days of check-in for each of 4 treatment periods involving an overnight stay at the study center.

You may not qualify if:

• 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.
• Clinically significant abnormal finding on physical examination, as determined by the investigator.
• Lifetime history of seizure disorder (other than childhood febrile seizures) or serious head injury.
• History of chronic insomnia or other sleep disorders, such as sleep apnea, narcolepsy, parasomnia, restless leg syndrome, or circadian rhythm disorder.
• Air travel across more than 2 time zones, an expected change in sleep schedule, or involvement in night work or shift work within 1 month before screening or during the study period.
• Reports a recent history of napping of more than once per week.
• History of alcohol or substance use disorder within the year before screening, or current evidence of alcohol or substance use disorder.
• Self-report of a usual consumption of more than 14 units of alcohol per week. One unit of alcohol is equivalent to 12 ounces of beer, 4 ounces of wine, or 1 ounce of liquor.
• Regular consumption of more than 500 mg of caffeine per day.
• History of routinely smoking during sleep period.
• Discontinuation of smoking or participation in a smoking cessation program within 30 days of screening or plans to discontinue smoking during the study.

Sponsors & Collaborators

• Sequential Medicine Ltd: lead

Study Sites (2)

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Thomas Dahl
• Organization: Sequential Medicine Ltd

tadahl@outlook.com

617-818-2735

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 6, 2017
• Study Start: October 9, 2017
• Primary Completion: March 20, 2018
• Study Completion: March 22, 2018
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2019-05

Locations

US (2)