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
Sponsor study identifier
interventional
67
0 countries
N/A
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
August 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 19, 2009
Actual (reported)April 9, 2009
Actual (reported)May 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Actual (reported)August 2011
Actual (reported)February 1, 2013
Actual (reported)Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)
Wake time After Sleep Onset hours 3-7 Pairwise comparisons of treatment group vs. placebo mean change from baseline in minutes per polysomnographic recording. Each patient receives baseline placebo and then each treatment dose at bedtime for two nights of sleep laboratory PSG measurements. The WASO3-7 mean of each two night visit is then used to compare placebo vs. treatment change from baseline minutes awake during hours 3 through 7 post-dose.
Hours 3-7 (inclusive) after tablet ingestion
WASO 1-8
Constantly throughout the 8 hour sleep period
Total Sleep Time 3-7 Hours Post-dose
hours 3-7 (inclusive) post-dose
Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)
hours 3-7 (inclusive) post-dose
Subjective Wake Time After Sleep Onset (sWASO)
9 hours after tablet ingestion
Digit Symbol Substitution Test
9 hours after tablet ingestion
Two placebo tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence
One 10 mg SKP-1041 controlled release zaleplon tablet plus one placebo tablet administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence
One 15 mg SKP-1041 controlled release zaleplon tablet plus one placebo tablet administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence
tablet at bedtime
tablet at bedtime
Questionnaires focused on initial insomnia as opposed to middle of the night awakening, short exposure to each dose, and lengthy washout periods between doses, may not allow for ideal assessment of subjective response to treatment.
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
67 participants (actual enrollment reported by the registry).
First Submitted
March 19, 2009
First Posted
April 9, 2009
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Two 10 mg SKP-1041 controlled release zaleplon tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
December 2010
Actual (reported)Study Completion
August 2011
Actual (reported)Last Updated
February 1, 2013
Results First Posted
February 1, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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