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

Sleep Disorder Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Patients will participate in the study for approximately 44 to 56 days, including a 14- to 21-day Screening Period, 4 Treatment Periods each followed by washout periods, and a final Follow-up Visit. Patients will receive their randomly assigned study medication and spend 2 nights in a sleep laboratory, subsequently returning home for a 4- to 7-day washout period between each treatment period. The fourth and final treatment period will include a third night at the site during which all patients will continue to receive the same study medication as on the first 2 nights of this treatment period. Blood will be drawn from all patients for pharmacokinetic analyses at specific time intervals. Patients will undergo final safety assessments 2 to 5 days after the last dose of study medication. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Primary Insomnia
• Sleep Disorder
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT00878553
• Study type: Interventional
• Source: Somnus Therapeutics, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Completion date: August 2011