SM-1 vs. an Active Comparator in A Model of Transient Insomnia

NCT04396327 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: SM-A-07
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 lorazepam during 2 one-night stays at a sleep center.

Conditions

Transient Insomnia

Keywords

Short term Insomnia

Outcome Measures

Primary Outcomes (1)

• Latency to Persistent Sleep (LPS)

  Time it takes to fall asleep

  8 hours

Secondary Outcomes (3)

• Wakefulness

  8 hours

• Subjective Sleep Latency

  8 hours

• Adverse Events

  8 hours

Other Outcomes (1)

• Total Sleep Time (TST)

  8 hours

Study Arms (2)

Active Comparator: 2-Drug Combination

ACTIVE COMPARATOR

50 mg diphenhydramine and 0.5 mg lorazepam

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

Drug: SM-1

Interventions

SM-1 DRUG

diphenhydramine, zolpidem and lorazepam

Active Treatment: SM-1 3-Drug Combination

Active Comparator DRUG

diphenhydramine and lorazepam

Active Comparator: 2-Drug Combination

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sequential Medicine Ltd: lead

Study Sites (1)

Clinilabs Drug Development Corporation

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

Study Officials

• Maha Ahmad, MD, MMSc

  Clinilabs Drug Development Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinilabs Drug Development Corporation

CONTACT

(212)994-4567; participate@clinilabs.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study will be double-blind. Neither study subjects nor study personnel will have knowledge of the treatments administered.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 20, 2020
• Study Start: May 27, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)