NCT00525941

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

An Exploratory Phase IIIb, Single-Blind, Outpatient Study to Assess Next-Day Functioning in Adult Primary Insomnia Patients Following the Administration of NBI-34060 Capsules During the Night

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	NBI-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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-09-06
• Last updated: 2015-05-12

Locations

4 sites across 1 country: United States