Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
NCT ID: NCT03312517
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2018-04-15
2018-10-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Suvorexant 10mg
Subjects will receive belsomra 10mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Suvorexant 10 mg
Subject will receive suvorexant 10mg
Suvorexant 20mg
Subjects will receive belsomra 20mg before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Suvorexant 20 mg
Subject will receive suvorexant 20mg
Placebo oral capsule
Subjects will receive placebo before bedtime. In the middle of the night, subjects will be awakened to auditory awakening tones.
Placebo oral capsule
Subject will receive placebo.
Interventions
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Suvorexant 10 mg
Subject will receive suvorexant 10mg
Suvorexant 20 mg
Subject will receive suvorexant 20mg
Placebo oral capsule
Subject will receive placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ISI ( Insomnia Severity Index) \> 10
* Age \>18 and \< 65
* Negative audiological screening exam
Exclusion Criteria
* 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
18 Years
64 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Christopher Drake
Principal Investigator
Principal Investigators
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Chris L Drake, PhD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Medical Center - Columbus
Novi, Michigan, United States
Countries
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References
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Greenblatt DJ, Harmatz JS, Shader RI. Update on Psychotropic Drug Prescribing in the United States: 2014-2015. J Clin Psychopharmacol. 2018 Feb;38(1):1-4. doi: 10.1097/JCP.0000000000000831. No abstract available.
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Drake CL, Durrence H, Cheng P, Roth T, Pillai V, Peterson EL, Singh M, Tran KM. Arousability and Fall Risk During Forced Awakenings From Nocturnal Sleep Among Healthy Males Following Administration of Zolpidem 10 mg and Doxepin 6 mg: A Randomized, Placebo-Controlled, Four-Way Crossover Trial. Sleep. 2017 Jul 1;40(7). doi: 10.1093/sleep/zsx086.
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Bruck D, Thomas IR. Smoke alarms for sleeping adults who are hard-of-hearing: comparison of auditory, visual, and tactile signals. Ear Hear. 2009 Feb;30(1):73-80. doi: 10.1097/AUD.0b013e3181906f89.
Rosenthal L, Bishop C, Helmus T, Krstevska S, Roehrs T, Roth T. Auditory awakening thresholds in sleepy and alert individuals. Sleep. 1996 May;19(4):290-5. doi: 10.1093/sleep/19.4.290.
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Drake CL, Kalmbach DA, Cheng P, Roth T, Tran KM, Cuamatzi-Castelan A, Atkinson R, Singh M, Tonnu CV, Fellman-Couture C. Can the Orexin Antagonist Suvorexant Preserve the Ability to Awaken to Auditory Stimuli While Improving Sleep? J Clin Sleep Med. 2019 Sep 15;15(9):1285-1291. doi: 10.5664/jcsm.7920.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MISP 57338
Identifier Type: -
Identifier Source: org_study_id
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