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
Results First Posted : November 1, 2019
Last Update Posted : November 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Drug: Suvorexant 10 mg Drug: Suvorexant 20 mg Drug: Placebo oral capsule||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||12 participants|
|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.|
|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|
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 Name: 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 Name: 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 Name: placebo
- 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.
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
|United States, Michigan|
|Henry Ford Medical Center - Columbus|
|Novi, Michigan, United States, 48377|
|Principal Investigator:||Chris L Drake, PhD||Henry Ford Health System|