Primary Insomnia
Conditions
Keywords
insomnia, sleep maintenance insomnia, sleep quality, non-restorative sleep, multiple awakenings
Brief summary
This study is designed to compare 2 doses of APD125 (20 mg and 40 mg) with placebo in otherwise healthy adults with primary insomnia primarily with complaints of maintaining sleep. Participants will be required to maintain a daily sleep dairy for up to 3 weeks while on study.
Interventions
DRUGAPD125
soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks
DRUGPlacebo
soft gelatin capsule, daily dosing for up to 3 weeks
Sponsors
Arena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, ages 18 to 65 years * Primary insomnia as defined in DSM-IV-TR, with predominant complaint of impaired sleep maintenance and confirmed by patient reported sleep diaries * 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in subjective number of awakenings after sleep onset (sNAASO) | During and after 2 weeks of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in subjective total sleep time (sTST) | During and after 2 weeks on study drug |
| Change from baseline in subjective wake time after sleep onset (sWASO) | During and after 2 weeks on study drug |
| Change in subjective latency to sleep onset (sSLO) | During and after 2 weeks on study drug |
| Safety and tolerability as assessed by changes from baseline in adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical laboratory values. | During and after 2 weeks on study drug |
Countries
United States
Outcome results
None listed