Transient InsomniaPhase 3NCT03338764
An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia
A Phase 3 study testing SM-1 in people with Transient Insomnia, run by Sequential Medicine Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Insomnia
- What is being tested?
- SM-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Transient Insomnia
- Being tested
- SM-1, Placebo
- Keywords
- Transient insomnia, Insomnia, Sleep initiation and maintenance disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM-1Drug
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
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental (SM-1) | Experimental | Drug: SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. Receives: Drug: SM-1 |
| Placebo | Placebo comparator | Drug: Placebo Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Total Sleep Time
Total time spent sleeping each night as reported by the subject
Measured: 7 nights
Secondary outcomes (4)
Pattern of use
Subject reported total number of uses and consecutive nights of use
Measured: 3 months
Safety Adverse Events
Adverse Events
Measured: Through study completion, 17 weeks
Safety Residual Effects
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
Measured: Through study completion, 17 weeks
Safety Rebound Insomnia
Total time spent sleeping each night as reported by the subject on night after taking drug or night after not taking drug
Measured: Through study completion, 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startMay 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequential Medicine Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338764
- Sponsor's protocol ID
- SM-A-06
- Status last verified
- Apr 2024
- First submitted
- 3 Nov 2017
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03338764
- Acronym / sponsor ID
- SM-A-06
- Conditions
- Transient Insomnia
- Keywords
- Transient insomnia, Insomnia, Sleep initiation and maintenance disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sequential Medicine LtdIndustry (pharma, biotech, devices)
- Study start
- May 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (SM-1) | Experimental | Drug: SM-1Drug: SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SM-1SM-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 | Drug | Experimental (SM-1) |
| PlaceboIdentical 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 | Drug | Placebo |
Primary outcome
Subjective Total Sleep Time
Time frame: 7 nights
Total time spent sleeping each night as reported by the subject
4 secondary outcomes
Pattern of use
Time frame: 3 months
Safety Adverse Events
Time frame: Through study completion, 17 weeks
Safety Residual Effects
Time frame: Through study completion, 17 weeks
Safety Rebound Insomnia
Time frame: Through study completion, 17 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Related trials for Transient Insomnia
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Sleep Restriction Therapy for Insomnia in Primary Health Care
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SM-1 vs. an Active Comparator in A Model of Transient Insomnia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SM-1 in people with Transient Insomnia, run by Sequential Medicine Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Total Sleep Time (time frame: 7 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.