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Study of Sleep-maintenance Activity of 3 Doses of SKP-1041

NCT00878553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2013-02-01

Study results available
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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.

Conditions

  • Sleep Disorder
  • Primary Insomnia

Interventions

DRUG

placebo

tablet at bedtime

DRUG

SKP-1041 (experimental formulation of zaleplon)

tablet at bedtime

Sponsors & Collaborators

  • INC Research Limited

    collaborator INDUSTRY

  • Somnus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon Freeman, PhD · Clinilabs, Inc.

  • Steven G. Hull, MD · Vince and Associates Clinical Research

  • Russell Rosenberg, PhD · Neurotrials Inc.

  • James K. Walsh, PhD · Sleep Medicine and Research Center

  • David J. Seiden, MD · Broward Research Group

  • Helene A. Emsellem, MD · Emsellem MD PC

  • D. Alan Lankford, PhD · Sleep Disorders Center of Georgia

  • Beth E. Safirstein, MD · MD Clinical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-12-31
Completion
2011-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878553 on ClinicalTrials.gov