Clinical trial NCT00878553: Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disorder
Primary Insomnia
Keywords: insomnia
middle of the night
sleep maintenance
Lead sponsor: Somnus Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: INC Research Limited
First posted: 2009-04-09
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Primary insomnia characterized by chronic difficulty maintaining sleep

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)
timeFrame: Hours 3-7 (inclusive) after tablet ingestion
Secondary outcomes:
measure: WASO 1-8
timeFrame: Constantly throughout the 8 hour sleep period
measure: Total Sleep Time 3-7 Hours Post-dose
timeFrame: hours 3-7 (inclusive) post-dose
measure: Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)
timeFrame: hours 3-7 (inclusive) post-dose
measure: Subjective Wake Time After Sleep Onset (sWASO)
timeFrame: 9 hours after tablet ingestion
measure: Digit Symbol Substitution Test
timeFrame: 9 hours after tablet ingestion
measure: Digit Span Test
timeFrame: 9 hours post-dose
measure: Visual Analog Scale (Sedation)
timeFrame: 9 hours after tablet ingestion
measure: Cmax Pharmacokinetic (PK) Profile Characterization
timeFrame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
measure: Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization
timeFrame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
measure: Tmax Pharmacokinetic (PK) Profile Characterization
timeFrame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
measure: AUC Pharmacokinetic (PK) Profile Characterization
timeFrame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
measure: AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization
timeFrame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
measure: Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization
timeFrame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
Other outcomes:
Locations:
Study officials:
affiliation: Clinilabs, Inc.
name: Jon Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vince and Associates Clinical Research
name: Steven G. Hull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurotrials Inc.
name: Russell Rosenberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Medicine and Research Center
name: James K. Walsh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Broward Research Group
name: David J. Seiden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emsellem MD PC
name: Helene A. Emsellem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Disorders Center of Georgia
name: D. Alan Lankford, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MD Clinical
name: Beth E. Safirstein, MD
role: PRINCIPAL_INVESTIGATOR
References: