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

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ClinicalTrials.gov Identifier: NCT03312517
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher Drake, Henry Ford Health System

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Insomnia Drug: Suvorexant 10 mg Drug: Suvorexant 20 mg Drug: Placebo oral capsule Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: double-blind, randomized 3-way crossover design
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Study is double blinded. Investigator, participant, or care provider will be blinded to watch drug the subject receives during each treatment week.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : October 25, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arm Intervention/treatment
Experimental: 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 Name: belsomra 10mg

Experimental: 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 Name: Belsomra 20mg

Experimental: 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 Name: placebo




Primary Outcome Measures :
  1. Auditory Awakening Threshold [ Time Frame: One year ]
    Subjects will be awakened during the night to auditory awakening tones.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312517


Locations
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United States, Michigan
Henry Ford Medical Center - Columbus
Novi, Michigan, United States, 48377
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Chris L Drake, PhD Henry Ford Health System
  Study Documents (Full-Text)

Documents provided by Christopher Drake, Henry Ford Health System:
Study Protocol  [PDF] August 25, 2017


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher Drake, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03312517     History of Changes
Other Study ID Numbers: MISP 57338
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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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
Keywords provided by Christopher Drake, Henry Ford Health System:
insomnia
belsomra
suvorexant
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action