NCT00525941

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

May 12, 2015

Status Verified

April 1, 2015

Enrollment Period

4 months

First QC Date

September 5, 2007

Last Update Submit

April 23, 2015

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

  • Assessments of Next-Day Function

    daily/six weeks

Secondary Outcomes (1)

  • Quality of Life

    biweekly/six weeks

Interventions

NBI-34060DRUG

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 Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sleep Disorders Center of Georgia

Atlanta, Georgia, 30342, United States

Location

Clinilabs, Inc.

New York, New York, 10019, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Tri-State Sleep Disorders Center

Cincinnati, Ohio, 45246, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Gary K. Zammit, PhD

    Clinilabs, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 12, 2015

Record last verified: 2015-04

Locations

US(4)