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
  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:
    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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014