Status:
COMPLETED
Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
Lead Sponsor:
Henry Ford Health System
Conditions:
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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
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 prop...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03312517
Start Date
April 15 2018
End Date
October 25 2018
Last Update
November 1 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Henry Ford Medical Center - Columbus
Novi, Michigan, United States, 48377