- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Two placebo tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence
|
tablet at bedtime
Other Names:
|
EXPERIMENTAL: 10 mg SKP-1041
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
|
tablet at bedtime
Other Names:
|
EXPERIMENTAL: 15 mg SKP-1041
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
Other Names:
|
EXPERIMENTAL: 20 mg SKP-1041
Two 10 mg SKP-1041 controlled release zaleplon tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence
|
tablet at bedtime
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7)
Time Frame: Hours 3-7 (inclusive) after tablet ingestion
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WASO 1-8
Time Frame: Constantly throughout the 8 hour sleep period
|
Wake Time After Sleep Onset, measured in minutes over the full 8 hour polysomnographic recording period, is summarized by treatment group for each night during the Screening and Treatment Periods.
|
Constantly throughout the 8 hour sleep period
|
Total Sleep Time 3-7 Hours Post-dose
Time Frame: hours 3-7 (inclusive) post-dose
|
Total Sleep Time during hours 3-7 (inclusive) post-dose
|
hours 3-7 (inclusive) post-dose
|
Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)
Time Frame: hours 3-7 (inclusive) post-dose
|
Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)
|
hours 3-7 (inclusive) post-dose
|
Subjective Wake Time After Sleep Onset (sWASO)
Time Frame: 9 hours after tablet ingestion
|
Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment
|
9 hours after tablet ingestion
|
Digit Symbol Substitution Test
Time Frame: 9 hours after tablet ingestion
|
Assessment of next-day residual cognitive effects.
The Digit Symbol Substitution Test (DSST) explores attention and psychomotor speed.
Given a code table displaying the correspondence between pairs of digits (from 1 to 9) and symbols, the patient filled in blank squares with the symbol that was paired with the digit displayed above the square.
The patient was required to fill in as many squares as possible in 180 seconds.
|
9 hours after tablet ingestion
|
Digit Span Test
Time Frame: 9 hours post-dose
|
Assessment of next day residual cognitive effects via testing immediate recall of numbers.
The patient was given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward.
The score was the number of correct responses, where the digits were repeated correctly.
One point was given for each correctly repeated string of digits.
The maximum subscore in the Digits Forward was 16, and the maximum subscore in the Digits Backward was 14, for a total score of 30.
|
9 hours post-dose
|
Visual Analog Scale (Sedation)
Time Frame: 9 hours after tablet ingestion
|
Self-assessment of next morning sedation.
Patients answered the question "How alert do you feel?" via a 100mm scale on which 0mm indicated "very sleepy" and 100mm indicated "wide awake and alert".The VAS measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end (in this case, sleepiness and alertness).
Patients were asked to mark the point on the line that they felt represented their current state.
The VAS score was determined by measuring in millimeters from the left-hand end of the line to the point that the patient marked.
|
9 hours after tablet ingestion
|
Cmax Pharmacokinetic (PK) Profile Characterization
Time Frame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
A detailed characterization of the Cmax (maximum plasma concentration of SKP-1041 zaleplon in ng/mL) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis). |
Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization
Time Frame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
A detailed characterization of Cmax/Dose (ng/mL/mg) (maximum plasma zaleplon concentration normalized per dose) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics, geometric means and 90% confidence intervals were calculated for dose-normalized values of Cmax. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis). |
Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
Tmax Pharmacokinetic (PK) Profile Characterization
Time Frame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
A detailed characterization of Tmax (hour) (timepoint post-dose of maximum plasma zaleplon concentration) PK profile of SKP-1041 zaleplon for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis). |
Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
AUC Pharmacokinetic (PK) Profile Characterization
Time Frame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
A detailed characterization of the AUC (area under the concentration-time curve of SKP-1041 zaleplon) for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics were calculated for AUC. Analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis). |
Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization
Time Frame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
A detailed characterization of the AUC/Dose (ng*h/mL/mg) [Area under the concentration-time curve per Dose of SKP-1041 zaleplon] for each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA) for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis). |
Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization
Time Frame: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
A detailed characterization of the plasma Half-Life (t1/2 in hours) of SKP-1041 zaleplon the each of the 3 study doses within the Pharmacokinetic Population (patients who completed the PK substudy--night 3 of Visit 6)with subsequent descriptive statistics comparing key PK characteristics across the 3 doses. Descriptive statistics and analysis of variance (ANOVA)for independent groups compared the three dosage groups using the untransformed values, as well as following rank transformation(nonparametric analysis). |
Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jon Freeman, PhD, Clinilabs, Inc.
- Principal Investigator: Steven G. Hull, MD, Vince and Associates Clinical Research
- Principal Investigator: Russell Rosenberg, PhD, Neurotrials Inc.
- Principal Investigator: David J. Seiden, MD, Broward Research Group
- Principal Investigator: Helene A. Emsellem, MD, Emsellem MD PC
- Principal Investigator: D. Alan Lankford, PhD, Sleep Disorders Center of Georgia
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Neurologic Manifestations
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Zaleplon
Other Study ID Numbers
- SOM201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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