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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00525941
• Other study ID #: NBI-34060-IR-0702
• Status: Withdrawn
• Phase: Phase 3
• First received: September 5, 2007
• Last updated: April 23, 2015
• Start date: September 2007
• Est. completion date: January 2008

Study information

• Verified date: April 2015
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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.

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Community Research	Cincinnati	Ohio
United States	Tri-State Sleep Disorders Center	Cincinnati	Ohio
United States	Clinilabs, Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessments of Next-Day Function		daily/six weeks
Secondary	Quality of Life		biweekly/six weeks