An Exploratory Study of NBI-34060 Capsules and Next Day F... | NCT00525941

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

NCT00525941

Sponsor

Neurocrine Biosciences

Status

Withdrawn

Last Update Posted

May 12, 2015Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Insomnia

Interventions

NBI-34060

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study discontinued due to Approvable decision

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 5, 2007

First Submission Date that Met QC Criteria

Sep 5, 2007

First Posted Date

Sep 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 27, 2011

Certification/Extension First Submitted that Passed QC Review

Jun 27, 2011

Certification/Extension First Posted Date

Jun 29, 2011Estimated

Last Update Submitted Date

Apr 23, 2015

Last Update Posted Date

May 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NBI-34060	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessments of Next-Day Function		daily/six weeks

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life		biweekly/six weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gary K. Zammit, PhD	Clinilabs, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sleep Disorders Center of Georgia		Atlanta	Georgia	30342	United States
Clinilabs, Inc.

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided