Sleep DisorderPhase 2NCT00878553
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
A Phase 2 study testing SKP-1041 (experimental formulation of zaleplon) in people with Sleep Disorder and Primary Insomnia, run by Somnus Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Sleep Disorder, Primary Insomnia
- What is being tested?
- SKP-1041 (experimental formulation of zaleplon)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary insomnia characterized by chronic difficulty maintaining sleep
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Sleep Disorder, Primary Insomnia
- Being tested
- placebo, SKP-1041 (experimental formulation of zaleplon)
- Keywords
- insomnia, middle of the night, sleep maintenance
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called sugar pill
tablet at bedtime
SKP-1041 (experimental formulation of zaleplon)Drug
Also called zaleplon
tablet at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two placebo tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence Receives: Drug: placebo |
| 10 mg SKP-1041 | Experimental | 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 Receives: Drug: SKP-1041 (experimental formulation of zaleplon) |
| 15 mg SKP-1041 | Experimental | 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 Receives: Drug: SKP-1041 (experimental formulation of zaleplon) |
| 20 mg SKP-1041 | Experimental | Two 10 mg SKP-1041 controlled release zaleplon tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence Receives: Drug: SKP-1041 (experimental formulation of zaleplon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hours 3-7 (inclusive) after tablet ingestion
Secondary outcomes (13)
WASO 1-8
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.
Measured: Constantly throughout the 8 hour sleep period
Total Sleep Time 3-7 Hours Post-dose
Total Sleep Time during hours 3-7 (inclusive) post-dose
Measured: hours 3-7 (inclusive) post-dose
Number of Awakenings After Sleep Onset During Hours 3 to 7 Post-dose (NAASO 3-7)
Number of Awakenings After Sleep Onset during hours 3-7 post-dose (inclusive) as measured with PSG (polysomnography)
Measured: hours 3-7 (inclusive) post-dose
Subjective Wake Time After Sleep Onset (sWASO)
Subjective wake time after sleep onset sourced from the Morning Sleep Questionnaire self-assessment
Measured: 9 hours after tablet ingestion
Digit Symbol Substitution Test
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.
Measured: 9 hours after tablet ingestion
Digit Span Test
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.
Measured: 9 hours post-dose
Visual Analog Scale (Sedation)
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.
Measured: 9 hours after tablet ingestion
Cmax Pharmacokinetic (PK) Profile Characterization
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).
Measured: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
Cmax/Dose(Dose-Normalized Cmax)Pharmacokinetic (PK) Profile Characterization
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).
Measured: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
Tmax Pharmacokinetic (PK) Profile Characterization
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).
Measured: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
AUC Pharmacokinetic (PK) Profile Characterization
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).
Measured: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
AUC/Dose (ng*h/mL/mg) Pharmacokinetic (PK) Profile Characterization
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).
Measured: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
Half-Life (t1/2 Hour) Pharmacokinetic (PK) Profile Characterization
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).
Measured: Blood samples drawn hourly from -1 to 10 hours post-dose (except hour 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somnus Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Responsible party
- Sponsor
- Investigators
- Jon Freeman, PhD, Principal investigator, Clinilabs, Inc.Steven G. Hull, MD, Principal investigator, Vince and Associates Clinical ResearchRussell Rosenberg, PhD, Principal investigator, Neurotrials Inc.James K. Walsh, PhD, Principal investigator, Sleep Medicine and Research CenterDavid J. Seiden, MD, Principal investigator, Broward Research GroupHelene A. Emsellem, MD, Principal investigator, Emsellem MD PCD. Alan Lankford, PhD, Principal investigator, Sleep Disorders Center of GeorgiaBeth E. Safirstein, MD, Principal investigator, MD Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878553
- Sponsor's protocol ID
- SOM201
- Status last verified
- Jan 2013
- First submitted
- 19 Mar 2009
- Last updated
- 1 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00878553
- Acronym / sponsor ID
- SOM201
- Conditions
- Sleep Disorder, Primary Insomnia
- Keywords
- insomnia, middle of the night, sleep maintenance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Somnus Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- INC Research Limited
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Posted 1 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboTwo placebo tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence |
| 10 mg SKP-1041 | Experimental | Drug: SKP-1041 (experimental formulation of zaleplon)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 |
| 15 mg SKP-1041 | Experimental | Drug: SKP-1041 (experimental formulation of zaleplon)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 |
| 20 mg SKP-1041 | Experimental | Drug: SKP-1041 (experimental formulation of zaleplon)Two 10 mg SKP-1041 controlled release zaleplon tablets administered orally at bedtime for two consecutive nights to each patient per crossover randomized sequence |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Primary insomnia characterized by chronic difficulty maintaining sleep
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: sugar pilltablet at bedtime | Drug | Placebo |
| SKP-1041 (experimental formulation of zaleplon)Also: zaleplontablet at bedtime | Drug | 10 mg SKP-1041, 15 mg SKP-1041, 20 mg SKP-1041 |
Primary outcome
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.
13 secondary outcomes
WASO 1-8
Time frame: Constantly throughout the 8 hour sleep period
Total Sleep Time 3-7 Hours Post-dose
Time frame: 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
Subjective Wake Time After Sleep Onset (sWASO)
Time frame: 9 hours after tablet ingestion
Digit Symbol Substitution Test
Time frame: 9 hours after tablet ingestion
Digit Span Test
Time frame: 9 hours post-dose
Visual Analog Scale (Sedation)
Time frame: 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)
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)
Tmax Pharmacokinetic (PK) Profile Characterization
Time frame: 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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sleep Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Freeman, PhD principal investigator
Clinilabs, Inc.
Steven G. Hull, MD principal investigator
Vince and Associates Clinical Research
Russell Rosenberg, PhD principal investigator
Neurotrials Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKP-1041 (experimental formulation of zaleplon) in people with Sleep Disorder and Primary Insomnia, run by Somnus Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake After Sleep Onset During Hours 3 to 7 Post-dose (WASO 3-7) (time frame: Hours 3-7 (inclusive) after tablet ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.