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Zaleplon AP formulation

Phase 2

Insomnia | Small molecule | Psychiatry |Indaptus Therapeutics, Inc.|Last Updated: Dec 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

Zaleplon AP formulation · 1 trial · 1 indication

Phase 2 1
NCT01277107A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With InsomniaInsomnia
COMPLETED83 Analytics
PHASE2COMPLETED
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia
Insomnia
NCT0127710783
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Study Endpoints

Primary Endpoints

To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST)
Polysomnography tests for 2 consecutive nights at each treatment arm

The change from baseline on the mean of drug nights 1 and 2 relative to placebo.

Secondary Endpoints

To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)
Polysomnography tests for 2 consecutive nights at each treatment arm
To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO)
Polysomnography tests for 2 consecutive nights at each treatment arm
To evaluate the presence of any residual effects using the digital symbol substitution test (DSST) and a memory test
2 consecutive mornings at each treatment arm
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Zaleplon AP formulationEXPERIMENTALGastric Retentive Dual Release Zaleplon (Zaleplon AP)
PlaceboPLACEBO_COMPARATORIdentical placebo capsule

Interventions

NameTypeDescription
Zaleplon AP formulationDRUGGastric retentive dual release Zaleplon
Placebo capsuleDRUGIdentical placebo capsule
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Subjects between the ages of 18 and 65 years of age * Subjects that meet DSM IV diagnostic criteria for Primary Insomnia * Subjects that report a time in bed ≥6.5 and ≤9 hours * Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST ≤6.5 hours * Subject...

Countries:United StatesIsrael
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Competitive Landscape -Insomnia and Sleep Disorders 11 trials (matched to "Insomnia")

CompanyTickerTrialsLead PhaseDrugs
Vanda Pharmaceuticals Inc.VNDA3PHASE3Tasimelteon
Merck & Co., Inc.MRK1PHASE3Suvorexant
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
ResMed Inc.RMD1N/AUndisclosed
IQVIA Holdings IncIQV1 - Daridorexant, Non-orexin receptor antagonist medications for insomnia
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Frequently asked questions about Zaleplon AP formulation

What is Zaleplon AP formulation used for?

Zaleplon AP formulation is an investigational small molecule being developed for the treatment of insomnia. It is a gastric retentive formulation of zaleplon, designed as an Accordion Pill for extended release. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Zaleplon AP formulation?

Zaleplon AP formulation is being developed by Indaptus Therapeutics, Inc., a company traded on the stock exchange under the ticker symbol INDP. The drug is an investigational product for insomnia and is currently in Phase 2 clinical trials.

What phase is Zaleplon AP formulation in?

Zaleplon AP formulation is in Phase 2 clinical development. It is an investigational drug for insomnia and has not yet been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation.

What clinical trials is Zaleplon AP formulation in?

Zaleplon AP formulation has one completed Phase 2 clinical trial, identified as NCT01277107. This was a randomized, double-blind, placebo-controlled polysomnographic study comparing the efficacy of the gastric retentive zaleplon Accordion Pill to placebo in subjects with insomnia. The trial enrolled 83 participants in the United States and Israel.

Is Zaleplon AP formulation the same as zaleplon?

Zaleplon AP formulation is a specific extended-release formulation of the drug zaleplon, designed as a gastric retentive Accordion Pill. While it contains the same active ingredient, the AP formulation is a distinct product being developed for insomnia with a modified release profile.