CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00878553
NCT00878553Phase 2Completed
CompareCT.gov

A Phase 2, Double-Blind, Placebo-Controlled, Double-Dummy, Cross-Over Study to Investigate the Hypnotic Activity of Three Doses (10mg, 15mg, 20mg) of a New Zaleplon Prototype, SKP-1041, in Adults With Primary Insomnia

Somnus Therapeutics, Inc.·interventional·Posted Apr 9, 2009·Updated Feb 1, 2013

In Brief

A Phase 2 clinical trial evaluating placebo and SKP-1041 (experimental formulation of zaleplon) for Sleep Disorder and Primary Insomnia. Completed, enrolled 67 participants.

Detailed Summary

SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is currently available as Sonata as well as several generic formulations. Sonata and its generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. It is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. This trial will determine the best dose to prevent those awakenings.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Disorder, Primary Insomnia
Countries--
CollaboratorsINC Research Limited

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2009
Enrollment StartMay 1, 2010
Primary CompletionDec 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.2 years ago

Interventions

placebodrug

tablet at bedtime

SKP-1041 (experimental formulation of zaleplon)drug

tablet at bedtime