Transient InsomniaPhase 2NCT04396327
SM-1 vs. an Active Comparator in A Model of Transient Insomnia
A Phase 2 study testing SM-1 and Active Comparator in people with Transient Insomnia, run by Sequential Medicine Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Transient Insomnia
- What is being tested?
- SM-1 and Active Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2020to 30 Jun 2020
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25 and 55 years
- Body mass index (BMI) between 19 and 32 kg/m2
- Report previous history of occasional difficulty falling asleep or staying asleep, but not currently having difficulty sleeping;
- Regular, habitual bedtime between 21:00 and 24:00, routinely spend at least 7.5 and no more than 9.0 hours in bed nightly and a bedtime that does not vary by more than 2 hours over the course of the week.
- Good general health
- Females of childbearing potential must be using an acceptable method of contraception, have a negative serum pregnancy test at screening and have a negative urine pregnancy test before randomization and prior to each Treatment Period.
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- Female subjects who have been surgically sterilized are eligible if they have a negative serum pregnancy test at screening and negative urine pregnancy test at check-in or are post-menopausal or have had a complete hysterectomy;
- Male subjects must use an acceptable method of contraception during the course of the study and for the 90 days following the last dose of study medication.
- Obtain signed informed consent
- Able to stay in the clinical research unit for 1 overnight stay during each treatment period
- No alcohol on check-in days
- Refrain from the use of alcohol and from napping on site check-in days
- A recent history of napping of no more than once per week.
Who cannot join
- Clinically significant, acute illness within 14 days prior to screening
- Clinically significant, unstable medical illness;
- Evidence or history of clinically significant allergic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease;
- History of cancer or diabetes;
- A sitting blood pressure > 140/90 millimeters mercury (mm/Hg) at screening;
- Heart rate > 100 beats per minute (BPM) at screening;
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- Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition;
- Subject has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the C-SSRS
- History or presence of chronic pain;
- Lifetime history of seizure disorder or serious head injury;
- Clinically significant sleep disorder, including chronic insomnia, sleep apnea, narcolepsy, parasomnia, restless leg syndrome or circadian rhythm disorder;
- Slept in a sleep laboratory at any time prior to Screening.
- STOP-BANG sleep apnea questionnaire >/= to 3 at Screening;
- Epworth Sleepiness Scale (ESS) score >10 at screening;
- Any condition that may affect drug absorption;
- Travel across more than three time zones or shift worker
- Any clinically significant abnormal finding on physical examination, vital signs or clinical laboratory tests,
- History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to diphenhydramine, zolpidem or lorazepam;
- Pregnant or lactating females;
- Positive serum or urine pregnancy test
- Positive urine drug screen
- Recent history or current evidence of alcohol or drug abuse
- Regular consumption of "large amounts" of xanthine-containing substances (i.e., [equivalent to approximately 2 - 3 cups of regular coffee] or equivalent amounts of xanthine-containing substances);
- Usual consumption of more than 14 units of alcohol per week.
- Use of more than 10 cigarettes or equivalent per day of any product containing nicotine or routinely smokes during sleep period.
- Stopped smoking or in a smoking cessation program within 90 days of screening;
- Use of restricted concomitant medications, any prescription drug, OTC medication, grapefruit, grapefruit juice, herbal preparation or food supplement, excluding vitamins, acetaminophen or hormonal contraceptives
- 29. Exposure to any investigational drug or to diphenhydramine, zolpidem or lorazepam or other drugs of the same pharmaceutical classes within 30 days of screening 30. Positive alcohol or drug test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Clinilabs Drug Development Corporation
New York, New York, 10019
About this study
Official title: A Randomized, Double-Blind, Single-Dose, 2-Way Cross-Over Study to Assess the Pharmacodynamic Effects of SM-1 vs. Active Comparator in a 3-Hour Phase Advance Model of Transient Insomnia
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 lorazepam during 2 one-night stays at a sleep center.
Read the detailed description
The purpose of this study is to evaluate the effect of a combination drug product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to determine the contribution of zolpidem to the combination, using a 3-hour Phase Advance model of sleep challenge with 8 hours of polysomnographic (PSG) recording. This is a 2-arm, 2-period crossover trial including the 3-drug investigational product and a 2-drug comparator. The 2 arms are: investigational combination product, and a 2-drug comparator containing diphenhydramine and lorazepam but not zolpidem. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who are generally healthy and do not have chronic insomnia or sleep apnea.
A total of 14 subjects are planned to enroll in the study. Subjects who qualify for participation will be asked to keep a sleep diary to document their sleep times leading up to their first overnight stay in the sleep center and during the study. Subjects will be asked to spend at least 7.5 hours in bed at a regular bedtime during the study. Qualifying participants also will not anticipate traveling across 3 time zones, be involved in night shift work, or significant disruptions in their sleep schedules during the study. The study requires 2 one-night stays in a sleep center in New York City, for administration of the study treatments and PSG \& EEG measurements. Qualifying subjects will anticipate being able to return to the sleep center, located in Manhattan, for a total of 3 visits, including initial screening and 2 treatment times.
Subjects will receive a follow up phone call from study staff 3 days after final dose of study medication.
During each sleep center visit, subjects will arrive to the sleep center approximately 5 hours prior to their average usual bedtime and will be given their study treatment. Their sleep will be monitored for 8 hours. Each subject will receive both treatments, although the sequence of the 2 treatments will be randomized. Both subjects and study personnel monitoring the subjects will be blinded to the identity of the treatment administered at each visit.
- Conditions
- Transient Insomnia
- Being tested
- SM-1, Active Comparator
- Keywords
- Short term Insomnia
- 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
diphenhydramine, zolpidem and lorazepam
Active ComparatorDrug
diphenhydramine and lorazepam
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: 2-Drug Combination | Active comparator | 50 mg diphenhydramine and 0.5 mg lorazepam Receives: Drug: Active Comparator |
| Active Treatment: SM-1 3-Drug Combination | Experimental | 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam Receives: Drug: SM-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to Persistent Sleep (LPS)
Time it takes to fall asleep
Measured: 8 hours
Secondary outcomes (3)
Wakefulness
Time spent awake in minutes
Measured: 8 hours
Subjective Sleep Latency
Time it takes to fall asleep in minutes
Measured: 8 hours
Adverse Events
Safety and tolerability assessed in terms of the incidence of AEs
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start27 May 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequential Medicine Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maha Ahmad, MD, MMSc, Principal investigator, Clinilabs Drug Development Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396327
- Sponsor's protocol ID
- SM-A-07
- Status last verified
- Apr 2020
- First submitted
- 8 May 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single-Dose, 2-Way Cross-Over Study to Assess the Pharmacodynamic Effects of SM-1 vs. Active Comparator in a 3-Hour Phase Advance Model of Transient Insomnia
- ClinicalTrials.gov ID
- NCT04396327
- Acronym / sponsor ID
- SM-A-07
- Conditions
- Transient Insomnia
- Keywords
- Short term Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Sequential Medicine LtdIndustry (pharma, biotech, devices)
- Study start
- 27 May 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 20 May 2020 (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 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 lorazepam during 2 one-night stays at a sleep center.
Detailed description
The purpose of this study is to evaluate the effect of a combination drug product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to determine the contribution of zolpidem to the combination, using a 3-hour Phase Advance model of sleep challenge with 8 hours of polysomnographic (PSG) recording. This is a 2-arm, 2-period crossover trial including the 3-drug investigational product and a 2-drug comparator. The 2 arms are: investigational combination product, and a 2-drug comparator containing diphenhydramine and lorazepam but not zolpidem. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who are generally healthy and do not have chronic insomnia or sleep apnea.
A total of 14 subjects are planned to enroll in the study. Subjects who qualify for participation will be asked to keep a sleep diary to document their sleep times leading up to their first overnight stay in the sleep center and during the study. Subjects will be asked to spend at least 7.5 hours in bed at a regular bedtime during the study. Qualifying participants also will not anticipate traveling across 3 time zones, be involved in night shift work, or significant disruptions in their sleep schedules during the study. The study requires 2 one-night stays in a sleep center in New York City, for administration of the study treatments and PSG \& EEG measurements. Qualifying subjects will anticipate being able to return to the sleep center, located in Manhattan, for a total of 3 visits, including initial screening and 2 treatment times.
Subjects will receive a follow up phone call from study staff 3 days after final dose of study medication.
During each sleep center visit, subjects will arrive to the sleep center approximately 5 hours prior to their average usual bedtime and will be given their study treatment. Their sleep will be monitored for 8 hours. Each subject will receive both treatments, although the sequence of the 2 treatments will be randomized. Both subjects and study personnel monitoring the subjects will be blinded to the identity of the treatment administered at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: 2-Drug Combination | Active comparator | Drug: Active Comparator50 mg diphenhydramine and 0.5 mg lorazepam |
| Active Treatment: SM-1 3-Drug Combination | Experimental | Drug: SM-13-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 25 and 55 years
- Body mass index (BMI) between 19 and 32 kg/m2
- Report previous history of occasional difficulty falling asleep or staying asleep, but not currently having difficulty sleeping;
- Regular, habitual bedtime between 21:00 and 24:00, routinely spend at least 7.5 and no more than 9.0 hours in bed nightly and a bedtime that does not vary by more than 2 hours over the course of the week.
- Good general health
Key exclusion criteria (28 listed)
- Clinically significant, acute illness within 14 days prior to screening
- Clinically significant, unstable medical illness;
- Evidence or history of clinically significant allergic hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease;
- History of cancer or diabetes;
- A sitting blood pressure > 140/90 millimeters mercury (mm/Hg) at screening;
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-1diphenhydramine, zolpidem and lorazepam | Drug | Active Treatment: SM-1 3-Drug Combination |
| Active Comparatordiphenhydramine and lorazepam | Drug | Active Comparator: 2-Drug Combination |
Primary outcome
Latency to Persistent Sleep (LPS)
Time frame: 8 hours
Time it takes to fall asleep
3 secondary outcomes
Wakefulness
Time frame: 8 hours
Subjective Sleep Latency
Time frame: 8 hours
Adverse Events
Time frame: 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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.
Maha Ahmad, MD, MMSc principal investigator
Clinilabs Drug Development Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SM-1 and Active Comparator in people with Transient Insomnia, run by Sequential Medicine Ltd at 1 site in United States.
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 13 inclusion and 28 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: opening soon, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinilabs Drug Development Corporation ((212)994-4567, participate@clinilabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency to Persistent Sleep (LPS) (time frame: 8 hours). 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 20 May 2020; AzTrials last refreshed its copy on 1 Nov 2026.