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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.