NCT00452179

Brief Summary

The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 10, 2007

Status Verified

September 1, 2007

First QC Date

March 23, 2007

Last Update Submit

September 6, 2007

Conditions

Insomnia

Keywords

Sleep maintenanceInsomniaSleep ConsolidationSleepInsomnia, primarily sleep maintenance

Outcome Measures

Primary Outcomes (1)

  • Conventional PSG parameters

Secondary Outcomes (1)

  • Patient reported subjective sleep parameters

Interventions

APD125DRUG

Eligibility Criteria

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

You may qualify if:

  • Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by PSG
  • PSQI \>/= to 5
  • Qualifying screening PSG parameters
  • Generally good health

You may not qualify if:

  • History of any sleep disorder, other than primary insomnia (e.g., restless leg syndrome, narcolepsy, sleep apnea, and disorders of REM/NREM sleep)
  • Any clinically significant medical condition, laboratory finding, or ECG finding
  • Pregnant and/or lactating females
  • History of substance abuse within 2 years or positive urine drug screen
  • Positive Hepatitis B/C results or HIV markers
  • Apnea-Hypopnea Index (AHI) or a Periodic Limb Movement Arousal Index (PLMAI) \> 10 as determined by screening PSG
  • History of treatment with an investigational drug within the last month
  • Recent travel involving crossing more than 3 time zones or plans to travel to another time zone (\> 3 time zones) during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, 92121, United States

Location

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Warren A Prosser

    Arena Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

February 1, 2007

Study Completion

June 1, 2007

Last Updated

September 10, 2007

Record last verified: 2007-09

Locations

US(1)