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

Primary Purpose

Insomnia

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NBI-34060
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Sleep Disorders Center of Georgia
  • Clinilabs, Inc.
  • Community Research
  • Tri-State Sleep Disorders Center

Outcomes

Primary Outcome Measures

Assessments of Next-Day Function

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
September 5, 2007
Last Updated
April 23, 2015
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00525941
Brief Title
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study discontinued due to Approvable decision
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NBI-34060
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessments of Next-Day Function
Time Frame
daily/six weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
biweekly/six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary K. Zammit, PhD
Organizational Affiliation
Clinilabs, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Clinilabs, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Tri-State Sleep Disorders Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States

12. IPD Sharing Statement

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

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