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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01196650

Enrollment

Registered

2010-09-08

Start date

2010-09-30

Completion date

Unknown

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGIN 10 003 formulation A

DRUGIN 10 003 formulation B

DRUGPlacebo capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Objective and Subjective sleep parameters	—	Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026