Phase 2
N=67
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
Sleep Disorder · Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00878553 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7) — -40.19; -48.79; -50.17; -49.34 minutes — p=0.0118
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo (Drug); SKP-1041 (experimental formulation of zaleplon) (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Somnus Therapeutics, Inc.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7) |
-40.19; -48.79; -50.17; -49.34 | 0.0118 sig |
| SECONDARY WASO 1-8 |
-44.65; -50.25; -51.56; -50.17 | 0.1476 |
| SECONDARY Total Sleep Time 3-7 Hours Post-dose |
39.03; 47.86; 49.46; 49.18 | 0.0092 sig |
| SECONDARY Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7) |
-1.40; -1.96; -2.43; -2.19 | 0.1005 |
| SECONDARY Subjective Wake Time After Sleep Onset (sWASO) |
-14.05; -22.50; -12.68; -25.89 | 0.2190 |
| SECONDARY Digit Symbol Substitution Test |
8.56; 9.26; 6.59; 9.95 | 0.6433 |
| SECONDARY Digit Span Test |
0.23; 0.71; 0.40; -0.02 | 0.0914 |
| SECONDARY Visual Analog Scale (Sedation) |
3.48; 3.83; 3.55; 4.96 | 0.7190 |
| SECONDARY Cmax Pharmacokinetic (PK) Profile Characterization |
17.9; 25.3; 34.4 | 0.0009 sig |
| SECONDARY Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization |
1.8; 1.7; 1.7 | 0.9142 |
| SECONDARY Tmax Pharmacokinetic (PK) Profile Characterization |
4; 4; 4 | 0.1193 |
| SECONDARY AUC Pharmacokinetic (PK) Profile Characterization |
56.5; 77.4; 135.3 | 0.0003 sig |
| SECONDARY AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization |
5.36; 5.20; 6.76 | 0.2281 |
| SECONDARY Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization |
1.52; 1.65; 1.47 | 0.4835 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00878553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.