Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia

NCT02671760 | Completed Phase 2 Results

• 1 other identifier: SM-A-02
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who do not have chronic insomnia. The study involves 3 one-night stays in a sleep center in New York City.

Conditions

Short-term Insomnia

Keywords

Short-term insomnia; difficulty sleeping; sedative; hypnotic

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time

  8 hours

Secondary Outcomes (6)

• Latency to Persistent Sleep

  8 hours

• Awakenings

  8 hours

• Latency to REM Sleep Onset

  8 hours

• Adverse Events

  8 hours

• Safety and Tolerability in Terms of Residual Sleepiness

  8 hours

Study Arms (3)

Treatment

EXPERIMENTAL

SM-1

Drug: SM-1

Comparator

ACTIVE COMPARATOR

2-drug combination

Drug: Comparator

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SM-1 DRUG

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

Treatment

Comparator DRUG

2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

Comparator

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 25 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) between 19 and 32 kg/m2, inclusive;
• Report occasional difficulty falling asleep or staying asleep;
• Report a regular, habitual bedtime between 21:00 and 24:00, routinely spend at least 7.5 and no more than 9.0 hours in bed each night and observe a bedtime that does not vary by more than 2 hours over the course of the week. Subjects will be required to complete at least 5 days of sleep information in a diary provided at the screening visit and returned to study personnel no later than 24 hours prior to check-in for the first overnight visit.
• Be in good general health as determined by a thorough medical history and physical examination including vital signs and clinical laboratory tests;
• 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. Acceptable methods of contraception include oral, intrauterine and injectable contraceptives or double barrier methods. After screening, subjects using oral contraceptives must agree to add a double barrier method until 30 days following the last dose of study medication. Female subjects relying on oral contraceptives must have been using them for at least one month prior to screening;
• 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 for Visits 2 and 3, or are post-menopausal as defined by the cessation of menses for a period of at least 2 years prior to screening or have had a complete hysterectomy;
• Male subjects must use an acceptable method of contraception during the course of the study and for the 30 days following the last dose of study medication. Acceptable methods of contraception include:
• Abstinence
• A condom and one of the following:
• i. Vasectomy for more than 6 months. ii. Female partner who meets one of the following conditions:
• Uses a spermicidal gel or foam; or
• Has had a tubal ligation, hysterectomy or bilateral oophorectomy; or
• Is post-menopausal (menopause is defined as over the age of 60 years, or between 45 and 60 years being amenorrheic for at least 2 years with plasma follicle stimulating hormone (FSH) level \> 30 UI/L); or
• Be able to read, understand, and provide written/dated informed consent before enrolling in the study and must be willing to comply with all study procedures;
• Be willing and able to be confined to the clinical research site for one night in each of 3 treatment periods as required by the protocol.

You may not qualify if:

• Clinically significant, acute illness within 14 days prior to screening (Visit 1).
• Clinically significant, unstable medical illness;
• Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease;
• History of cancer or diabetes;
• A supine 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;
• History or presence of chronic pain;
• Lifetime history of seizure disorder or serious head injury;
• Clinically significant sleep disorder, including insomnia, sleep apnea, narcolepsy, parasomnia, restless leg syndrome or circadian rhythm disorder;
• Any condition that may affect drug absorption;
• Travel across more than three time zones, an expected change in sleep schedule or involvement in night shift work within one month prior to screening or during the study period;
• Any clinically significant abnormal finding on physical examination, vital signs or clinical laboratory tests, as determined by the Investigator;
• History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to diphenhydramine, zolpidem or lorazepam;
• Pregnant or lactating females;

Sponsors & Collaborators

• Sequential Medicine Ltd: lead
• Clinilabs, Inc.: collaborator

Related Publications (1)

• Dahl T, Chen LB, Zammit G, Ahmad M, Roth T. Efficacy of SM-1 in a transient insomnia model. Hum Psychopharmacol. 2019 Nov;34(6):e2713. doi: 10.1002/hup.2713.

  PMID: 31837050 DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Head of Product Development
• Organization: Sequential Medicine Ltd

tadahl@outlook.com

617-818-2735

Study Officials

• Thomas Dahl, PhD

  Sequential Medicine Ltd

  STUDY DIRECTOR

• Maha Ahamad, MD

  Clinilabs, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 2, 2016
• Study Start: February 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 6, 2018
• Results First Posted: March 6, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share