NCT03312517

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Suvorexant 10 mg	Subject will receive suvorexant 10mg
DRUG	Suvorexant 20 mg	Subject will receive suvorexant 20mg
DRUG	Placebo oral capsule	Subject will receive placebo.

Timeline

• Start date: 2018-04-15
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2017-10-17
• Last updated: 2019-11-01
• Results posted: 2019-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study