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

This study has been terminated.

(Study discontinued due to Approvable decision)

Sponsor:

Information provided by:

Neurocrine Biosciences

ClinicalTrials.gov Identifier:

NCT00525941

First received: September 5, 2007

Last updated: July 12, 2011

Last verified: July 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: NBI-34060	Phase 3

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

Further study details as provided by Neurocrine Biosciences:

Primary Outcome Measures:

Assessments of Next-Day Function [ Time Frame: daily/six weeks ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: biweekly/six weeks ]

Enrollment:	0
Study Start Date:	September 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525941

Locations

United States, Georgia
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
United States, New York
Clinilabs, Inc.
New York, New York, United States, 10019
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45227
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States, 45246

Sponsors and Collaborators

Neurocrine Biosciences

Investigators

Principal Investigator:

Gary K. Zammit, PhD

Clinilabs, Inc.

More Information

No publications provided

Responsible Party:	Christopher O'Brien, Chief Medical Officer, Neurocrine Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT00525941 History of Changes
Other Study ID Numbers:	NBI-34060-IR-0702
Study First Received:	September 5, 2007
Last Updated:	July 12, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Indiplon
GABA Modulators
GABA Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013

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