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

NCT03312517 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MISP 57338
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia

Keywords

insomnia; belsomra; suvorexant

Outcome Measures

Primary Outcomes (1)

• Auditory Awakening Threshold

  Subjects will be awakened during the night to auditory awakening tones.

  2.5 hours post-dose of each Study Drug administration

Study Arms (3)

Suvorexant 10mg

ACTIVE COMPARATOR

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

Suvorexant 20mg

ACTIVE COMPARATOR

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

Placebo oral capsule

SHAM COMPARATOR

Subjects will receive placebo before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.

Drug: Placebo oral capsule

Interventions

Suvorexant 10 mg DRUG

Subject will receive suvorexant 10mg

Also known as: belsomra 10mg

Suvorexant 10mg

Suvorexant 20 mg DRUG

Subject will receive suvorexant 20mg

Also known as: Belsomra 20mg

Suvorexant 20mg

Placebo oral capsule DRUG

Subject will receive placebo.

Also known as: placebo

Placebo oral capsule

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Medical Center - Columbus

Novi, Michigan, 48377, United States

Location

Related Publications (20)

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  PMID: 31538599 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Christopher Drake, PhD
• Organization: Henry Ford Sleep Research Center

cdrake1@hfhs.org

248-344-6672

Study Officials

• Chris L Drake, PhD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Study is double blinded. Investigator, participant, or care provider will be blinded to watch drug the subject receives during each treatment week.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: double-blind, randomized 3-way crossover design

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: April 15, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: November 1, 2019
• Results First Posted: November 1, 2019

Record last verified: 2019-10

Locations

US (1)