Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo

Official Title
-----------------
A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Conditions
-----------------
Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep

Intervention / Treatment
-----------------
* Drug: IN 10 003 formulation A
* Drug: IN 10 003 formulation B
* Drug: Placebo capsules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between the ages of 18 and 65 years of age Subjects that meet DSM IV diagnostic criteria for Insomnia Subjects that report a time in bed NLT 6.5 and NMT 9 hours Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights Exclusion Criteria: Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first. Subject with a history (past year) of alcohol or substance abuse Subject that needs to smoke during the sleep period time Subject that reports habitual napping (more than 3 times per week)

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>IN 10 003 formulation A | Drug: IN 10 003 formulation A<br> <br> |
| Active Comparator: 2<br>IN 10 003 formulation B | Drug: IN 10 003 formulation B<br> <br> |
| Placebo Comparator: 3<br>Placebo capsules | Drug: Placebo capsules<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake after sleep onset | To determine the effect of IN 10 003 on Wake time After Sleep Onset (WASO) as the change from baseline for the mean of night 1 and 2 relative to placebo |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective and Subjective sleep parameters | Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects, |  |