Status:
COMPLETED
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
Lead Sponsor:
Somnus Therapeutics, Inc.
Collaborating Sponsors:
INC Research Limited
Conditions:
Sleep Disorder
Primary Insomnia
Eligibility:
All Genders
21-64 years
Phase:
PHASE2
Brief 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...
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. P...
Eligibility Criteria
Inclusion
- Primary insomnia characterized by chronic difficulty maintaining sleep
Exclusion
- History of restless legs syndrome, sleep apnea, narcolepsy, or parasomnias;
- Any clinically relevant acute or chronic diseases which could interfere with the patient's safety during this trial or with this tablet's absorption;
- Pregnancy;
- History of medication allergies;
- Use of medication that might interfere with this study;
- Recent travel across more than 3 time zones.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00878553
Start Date
May 1 2010
End Date
August 1 2011
Last Update
February 1 2013
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