Safety and Efficacy Study of APD125 in Patient With Insomnia
Phase 2
Completed
- Conditions
- Insomnia
- Registration Number
- NCT00452179
- Lead Sponsor
- Arena Pharmaceuticals
- Brief Summary
The purpose of this study is to determine the effects of APD125 in patients with sleep maintenance insomnia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Conventional PSG parameters
- Secondary Outcome Measures
Name Time Method Patient reported subjective sleep parameters