- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00525941
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
April 23, 2015 updated by: Neurocrine Biosciences
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
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.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30342
- Sleep Disorders Center of Georgia
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New York
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New York, New York, United States, 10019
- Clinilabs, Inc.
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Ohio
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Cincinnati, Ohio, United States, 45227
- Community Research
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Cincinnati, Ohio, United States, 45246
- Tri-State Sleep Disorders Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessments of Next-Day Function
Time Frame: daily/six weeks
|
daily/six weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of Life
Time Frame: biweekly/six weeks
|
biweekly/six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gary K. Zammit, PhD, Clinilabs, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 5, 2007
First Submitted That Met QC Criteria
September 5, 2007
First Posted (Estimate)
September 6, 2007
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
April 23, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Modulators
- GABA Agents
- Indiplon
Other Study ID Numbers
- NBI-34060-IR-0702
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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