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IN 10 003 formulation A

Phase 2

Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep | Small molecule | Other |Indaptus Therapeutics, Inc.|Last Updated: May 3, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

IN 10 003 formulation A · 1 trial · 1 indication

Phase 2 1
NCT01196650Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying AsleepSubjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
COMPLETED24 Analytics
PHASE2COMPLETED
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying AsleepUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Objective and Subjective sleep parameters
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORIN 10 003 formulation A
2ACTIVE_COMPARATORIN 10 003 formulation B
3PLACEBO_COMPARATORPlacebo capsules

Interventions

NameTypeDescription
IN 10 003 formulation ADRUG -
IN 10 003 formulation BDRUG -
Placebo capsulesDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 * Subjec...

Countries:Israel
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Frequently asked questions about IN 10 003 formulation A

What is IN 10 003 formulation A used for?

IN 10 003 formulation A is an investigational small molecule being studied for the treatment of insomnia in subjects who have difficulty falling asleep and staying asleep. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes IN 10 003 formulation A?

IN 10 003 formulation A is being developed by Indaptus Therapeutics, Inc., a company listed on the stock exchange under the ticker symbol INDP. The drug is currently in Phase 2 clinical development for insomnia.

What phase is IN 10 003 formulation A in?

IN 10 003 formulation A is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed for this drug.

What clinical trials is IN 10 003 formulation A in?

IN 10 003 formulation A has one completed Phase 2 clinical trial, identified as NCT01196650. This trial compared IN 10 003 to placebo in subjects with insomnia suffering from difficulty falling asleep and staying asleep. The trial was conducted in Israel with 24 participants.

Is IN 10 003 formulation A the same as IN 10 003?

IN 10 003 formulation A is a specific formulation of the drug IN 10 003. The clinical trial NCT01196650 refers to the drug as IN 10 003, and the formulation A designation indicates a particular version being studied for insomnia.