Safety and Efficacy Study of APD125 in Patient With Insomnia

This study has been completed.

First Received: March 23, 2007 Last Updated: September 6, 2007 History of Changes

Sponsored by:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00452179

Purpose

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

Condition	Intervention	Phase
Insomnia	Drug: APD125	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

Secondary Outcome Measures:

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452179

Locations

United States, California

San Diego, California, United States, 92121

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Study Director:

Warren A Prosser

Arena Pharmaceuticals

More Information

Additional Information:

Arena Pharmaceuticals Home Page This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	APD125-004
Study First Received:	March 23, 2007
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00452179 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Arena Pharmaceuticals:

Sleep maintenance
Insomnia
Sleep Consolidation
Sleep
Insomnia, primarily sleep maintenance

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 10, 2009