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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

IN 10 003 formulation A

Group Type ACTIVE_COMPARATOR

IN 10 003 formulation A

Intervention Type DRUG

2

IN 10 003 formulation B

Group Type ACTIVE_COMPARATOR

IN 10 003 formulation B

Intervention Type DRUG

3

Placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type DRUG

Interventions

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IN 10 003 formulation A

Intervention Type DRUG

IN 10 003 formulation B

Intervention Type DRUG

Placebo capsules

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No