An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
Phase 3
Withdrawn
- Conditions
- Insomnia
- Registration Number
- NCT00525941
- Lead Sponsor
- Neurocrine Biosciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assessments of Next-Day Function daily/six weeks
- Secondary Outcome Measures
Name Time Method Quality of Life biweekly/six weeks
Trial Locations
- Locations (4)
Sleep Disorders Center of Georgia
🇺🇸Atlanta, Georgia, United States
Clinilabs, Inc.
🇺🇸New York, New York, United States
Tri-State Sleep Disorders Center
🇺🇸Cincinnati, Ohio, United States
Community Research
🇺🇸Cincinnati, Ohio, United States