Safety and Efficacy Study of APD125 in Patient With Insomnia

• Sponsor: Arena Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00452179
• Collaborator: (none)
• Enrollment: 173
• Location: 1
• Duration (Months): 3.9
• Patients Per Site Per Month: 43.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: APD125	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 173 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

Primary Outcome Measures

1. Conventional PSG parameters []

Secondary Outcome Measures

1. Patient reported subjective sleep parameters []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States	92121

Sponsors and Collaborators

• Arena Pharmaceuticals

Investigators

• Study Director: Warren A Prosser, Arena Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Arena Pharmaceuticals Home Page

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00452179
• Other Study ID Numbers: APD125-004
• First Posted: Mar 27, 2007
• Last Update Posted: Sep 10, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: Sleep maintenance; Insomnia; Sleep Consolidation; Sleep; Insomnia, primarily sleep maintenance
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Sep 10, 2007