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Safety and Efficacy Study of APD125 in Patient With Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
APD125
Sponsored by
Arena Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Sleep maintenance, Insomnia, Sleep Consolidation, Sleep, Insomnia, primarily sleep maintenance

Eligibility Criteria

18 Years - 64 Years (Adult)All Sexes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Outcomes

Primary Outcome Measures

Conventional PSG parameters

Secondary Outcome Measures

Patient reported subjective sleep parameters

Full Information

First Posted
March 23, 2007
Last Updated
September 6, 2007
Sponsor
Arena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00452179
Brief Title
Safety and Efficacy Study of APD125 in Patient With Insomnia
Official Title
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Cross-Over Study to Evaluate the Effects of APD125 in Patients With Chronic Primary Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arena Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Sleep maintenance, Insomnia, Sleep Consolidation, Sleep, Insomnia, primarily sleep maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
APD125
Primary Outcome Measure Information:
Title
Conventional PSG parameters
Secondary Outcome Measure Information:
Title
Patient reported subjective sleep parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren A Prosser
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.arenapharm.com
Description
Arena Pharmaceuticals Home Page

Learn more about this trial

Safety and Efficacy Study of APD125 in Patient With Insomnia

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