A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period Adaptive Crossover Polysomnography Study to Evaluate the Safety and Efficacy of MK 6096 in Patients with Primary Insomnia
- Conditions
- Primary insomnia
- Registration Number
- EUCTR2009-015773-12-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 328
Patient is male or female between 18 and < 65 years of age.
Patient has a DSM-IV-TR diagnosis of Primary Insomnia based on the investigator’s judgment and the patient’s sleep history as assessed on the Sleep Diagnostic Interview/Sleep History.
Patient reports on at least 3 out of 7 nights each week during the 4 weeks prior to Visit 1 (when not medicated on a hypnotic agent) each of the following:
?Total sleep time of = 6.5 hours;
?Sleep latency of = 30 minutes;
?= 1 hour of wakefulness after sleep onset; and
?Spending 6.5 to 9 hours nightly in bed.
Patient is willing to stay in bed for at least 8 hours each night while at the sleep laboratory.
The patient’s regular bedtime is between 9 PM (21:00) and 12 AM (00:00).
Screening PSG Inclusion (Visit 2)
Patient has LPS > 20 minutes during the Screening PSG at Visit 2. NOTE: Persistent sleep” is defined as the first continuous 20 epochs (30 seconds each) of a non-wake state.
Patient has WASO > 45 minutes during the Screening PSG at Visit 2.
Baseline PSG Inclusion (Visit 3)
Patient has LPS > 20 minutes on both Screening and Baseline PSG nights.
Patient has a mean WASO = 60 minutes on the combined Screening and Baseline PSG nights, where neither night is = 45 minutes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patient has any history of a neurological disorder, including but not limited to seizure disorder (other than single episodes of childhood febrile seizures), stroke, transient ischemic attack, multiple sclerosis, cognitive impairment or significant head trauma with sustained loss of consciousness in the last 10 years.
Patient has any of the following:
?A lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder;
?A psychiatric condition requiring treatment with a prohibited medication; or
?Other current psychiatric condition that, in the investigator's opinion, would interfere with the patient's ability to participate in the study.
Patient has evidence of ongoing depression (e.g., = 20 on the Quick Inventory of Depressive Symptomatology – Self Report Scale (QIDS-SR16), or suicidality (e.g., = 2 on the QIDS-SR16 suicide item #12), or, in the investigator's opinion, is impaired in such a way as to be unable to complete the study procedures in a safe and appropriate fashion (regardless of QIDS-SR16 score).
Patient has a history of substance abuse or dependence (except if currently in sustained full remission for at least one year or meets criteria for early full remission, according to DSM-IV-TR).
Patient has a history of transmeridian travel (across > 3 time zones) or shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates needing to travel (across > 3 time zones) at any time during the study.
Patient has a history of any of following conditions:
a.Narcolepsy
b.Idiopathic cataplexy
c.Circadian rhythm sleep disorder
d.Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and REM behavior disorder
e.Sleep-related breathing disorder
f.Periodic limb movement disorder
g. Restless legs syndrome
Screening PSG Exclusion (Visit 2)
Patient has an underlying pathology of sleep identified during the screening PSG:
a.An Apnea Hypopnea Index >10
b.>10 periodic leg movements associated with an arousal per hour of sleep (PLMAs).
Patient has a positive alcohol breath test as analyzed by a breathalyzer machine.
Baseline & Treatment Day 1 PSG Exclusion (Visits 3 & 4)
Patient has a positive alcohol breath test or urine drug screen.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of MK-6096 compared with placebo in improving sleep efficiency (SE) as measured by polysomnography (PSG) on Night 1 and at the end of 4 weeks of treatment, where SE is defined as 100 times total sleep time (minutes) divided by time in bed (minutes). And, to evaluate the safety and tolerability of MK-6096.;Secondary Objective: To evaluate the efficacy of MK-6096 compared with placebo in improving wake after sleep onset (WASO) as measured by PSG on Night 1 and at the end of 4 weeks of treatment. And, to evaluate the efficacy of MK-6096 compared with placebo in improving latency to persistent sleep (LPS) as measured by PSG on Night 1 and at the end of 4 weeks of treatment.;Primary end point(s): Sleep efficiency (SE) at Night 1 and at the end of 4 weeks of treatment, as derived from total sleep time (TST), based on polysomnography (PSG) results
- Secondary Outcome Measures
Name Time Method