An Exploratory Study of NBI-34060 Capsules and Next Day Functioning

Neurocrine Biosciences

Status and phase: Withdrawn; Phase 3

Conditions: Insomnia

Treatments: Drug: NBI-34060

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525941

NBI-34060-IR-0702

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind