NCT00878553

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Somnus Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sleep Disorder
• Primary Insomnia

Interventions

Type	Name	Description
DRUG	placebo	tablet at bedtime
DRUG	SKP-1041 (experimental formulation of zaleplon)	tablet at bedtime

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-12-01
• Completion: 2011-08-01
• First posted: 2009-04-09
• Last updated: 2013-02-01
• Results posted: 2013-02-01