Subjective Study to Assess the Efficacy of APD125 in Patients With Sleep Maintenance Insomnia

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Subjective Study to Assess the Efficacy of APD125 in Patients With Primary Insomnia Characterized by Difficulty Maintaining Sleep

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: APD125
* Drug: APD125
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>APD125 20 mg | Drug: APD125<br>* soft gelatin capsule, 20 mg, daily dosing for up to 3 weeks<br>|
| Experimental: 2<br>APD125 40 mg | Drug: APD125<br>* soft gelatin capsule, 40 mg, daily dosing for up to 3 weeks<br>|
| Placebo Comparator: 3<br>Matching Placebo | Drug: Placebo<br>* soft gelatin capsule, daily dosing for up to 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in subjective number of awakenings after sleep onset (sNAASO) |  | During and after 2 weeks of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, sleep maintenance insomnia, sleep quality, non-restorative sleep, multiple awakenings