Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs

October 30, 2019 updated by: Christopher Drake, Henry Ford Health System

A Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (Responsivity) of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs

Phase IV 3-Way Double-blind, Randomized, Crossover Study to Compare the Awakening Threshold Effects (responsivity) of Belsomra 10 mg and 20 mg to Placebo in non-elderly Insomniacs

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is an interventional single site study using a double blind, randomized 3-way crossover design with Belsomra 10 mg and 20 mg compared to a placebo. The total number of enrolled patients proposed is 12. A cross-over design is utilized so participants will be exposed to all treatment conditions in a controlled order (Belsomra 10 mg, 20 mg and placebo). Both men and women with insomnia will be utilized as the study population to improve the generalizability of outcome data. Subjects with other sleep disorders or unstable medical/psychiatric disorders will be excluded from the trial. Inclusion criteria will be men and women >18 and < 65 years of age.

Subjects will be randomly assigned to treatment sequences using a Latin square design. After a subject has qualified for the study, the next sequentially available randomization number will be assigned. The subject will be administered study drug corresponding with this assigned number.

During the night of each respective Polysomnography (PSG) assessments, subjects will be awoken at the approximate T-max of the active drug (2.5 hrs), with a matching placebo condition at the same time point using an identical responsivity protocol for each condition. The rationale for this is that t-max represents the time of greatest potential risk for a hypnotic in terms of balance, responsivity, and memory. Responsivity will be assessed using the Auditory Awakening Threshold test (AAT) and will be measured at 2.5 hours post dose for the Belsomra 10 and 20 mg (BEL), and placebo (PBO) conditions. Responsivity will be assessed at the approximate time above immediately after 5 minutes of consolidated (without arousals) NREM ( Non- rapid eye movement) stage 2 sleep has occurred.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Medical Center - Columbus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Meets DSM-5 ( Diagnostic and statistical manual) diagnostic criteria for insomnia disorder
  • ISI ( Insomnia Severity Index) > 10
  • Age >18 and < 65
  • Negative audiological screening exam

Exclusion Criteria:

  • BMI >35 kg/m2
  • Have symptoms consistent with the diagnosis of any sleep disorder other than insomnia (e.g., sleep apnea, narcolepsy, periodic leg movements, or restless leg syndrome).
  • Have a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS), or have tested seropositive for human immunodeficiency virus (HIV) antibody or antigen previously.
  • Have any clinically significant abnormal finding in physical examination, neurological assessment, vital signs, elevated body temperature, or clinical laboratory tests, as determined by the Investigator.
  • Have a known or exaggerated pharmacological sensitivity, hypersensitivity, or intolerance to Belsomra.
  • Currently taking CYP3A inhibitors.
  • Positive breathalyzer test for alcohol at Screening, PSG Screening or any Treatment night, or a positive urine drug screen (for amphetamines, barbiturates, benzodiazepines, cocaine, opiates, or cannabinoids) at Screening;
  • History of hearing difficulty (e.g., use of a hearing aid).
  • Intends to use any medication including over-the-counter (OTC) medications that would interfere with normal sleep architecture (such as systemic steroids, beta-adrenergic blockers, amphetamines, modafinil, etc.);
  • Self-reports use of products containing nicotine of greater than 15 cigarettes daily, or cannot avoid products containing nicotine during the normal sleep periods;
  • Self report consumption of more than five alcoholic beverages on any one day or > 14 alcoholic beverages weekly over the past week;
  • Have a history of epilepsy or serious head injury
  • Average Time in Bed < 6.5 hrs.
  • Have used prescribed or OTC medications within 7 days of screening (Day 0) or intend to use any prescription or OTC medication during the study that may interfere with the evaluation of the study drug. This restriction includes taking medications that affect the Central nervous system. Any chronic maintenance therapy should have been maintained at a stable dosing regimen for at least 30 days before screening and subjects must continue this regimen throughout the study.
  • Have used an investigational drug within 30 days or five half lives (whichever is longer) before screening, or plans to use an investigational drug during the study or have used belsomra or zolpidem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suvorexant 10mg
Subjects will receive belsomra 10mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Drug: Suvorexant 10 mg
Subject will receive suvorexant 10mg
Other Names:
  • belsomra 10mg
Active Comparator: Suvorexant 20mg
Subjects will receive belsomra 20mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Drug: Suvorexant 20 mg
Subject will receive suvorexant 20mg
Other Names:
  • Belsomra 20mg
Sham Comparator: Placebo oral capsule
Subjects will receive placebo before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Drug: Placebo oral capsule
Subject will receive placebo.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory Awakening Threshold
Time Frame: 2.5 hours post-dose of each Study Drug administration
Subjects will be awakened during the night to auditory awakening tones.
2.5 hours post-dose of each Study Drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: Chris L Drake, PhD, Henry Ford Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2018

Primary Completion (Actual)

October 25, 2018

Study Completion (Actual)

October 25, 2018

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISP 57338

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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