Insomnia
Conditions
Brief summary
NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel during the next day after dosing with NBI-34060. The study will also examine the pattern and extent of nighttime awakenings as reported by the patients, as well as and the patient's sleep experience during treatment.
Interventions
DRUGNBI-34060
10 mg capsules; dosed as needed for falling back asleep after a bothersome awakening provided there are at least 4 hours remaining in bed; no more than one dose per night.
Sponsors
Neurocrine Biosciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* insomnia (DSM-IV diagnosed; at least one month) * Nocturnal awakenings * Usual bedtimes between 9:00PM and Midnight. * Bedtimes that do not vary by more than 2 hours on 5 or more nights per week. * A usual time in bed of 7 to 9 hours.
Exclusion criteria
* no serious concomitant illness * no other condition that could interfere with sleep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessments of Next-Day Function | daily/six weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life | biweekly/six weeks |
Countries
United States
Outcome results
None listed