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WithdrawnNCT00525941Updated May 12, 2015

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

A Phase 3 interventional study of NBI-34060 in Insomnia, sponsored by Neurocrine Biosciences. Withdrawn at 4 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by Neurocrine Biosciences · Phase 3, Interventional, and Treatment

Why this study was withdrawn
Study discontinued due to Approvable decision
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
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Study 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.

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Conditions studied

03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • no serious concomitant illness
  • no other condition that could interfere with sleep
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
0 participants (actual)

Interventions

  • DrugNBI-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.

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What researchers measure

Primary outcomes

  1. Assessments of Next-Day Function

    Time frame: daily/six weeks

Secondary outcomes

  1. Quality of Life

    Time frame: biweekly/six weeks

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00525941
Lead sponsor
Neurocrine Biosciences
First posted
Sep 6, 2007
Start date
Sep 2007
Primary completion
Jan 2008
Completion
Jan 2008
Last update
May 12, 2015

Study contacts

Gary K. Zammit, PhD
principal investigator · Clinilabs, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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