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

NCT01196650 | Completed Phase 2

• 1 other identifier: IN 10 003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Objective and Subjective sleep parameters

Study Arms (3)

1

ACTIVE COMPARATOR

IN 10 003 formulation A

Drug: IN 10 003 formulation A

2

ACTIVE COMPARATOR

IN 10 003 formulation B

Drug: IN 10 003 formulation B

3

PLACEBO COMPARATOR

Placebo capsules

Drug: Placebo capsules

Interventions

IN 10 003 formulation A DRUG

1

IN 10 003 formulation B DRUG

2

Placebo capsules DRUG

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Intec Pharma Ltd.: lead

Study Sites (3)

Soroka University Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Assuta Medical Center

Tel Aviv, Israel

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 5, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2010
• Last Updated: May 3, 2011

Record last verified: 2010-09

Locations

IL (3)