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 insomniaMedDRA version: 12.0Level: LLTClassification code 10036701Term: Primary insomnia
- Registration Number
- EUCTR2009-015773-12-GB
- Lead Sponsor
- Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 328
1. Patient is male or female between 18 and < 65 years of age on the day of signing
informed consent.
2. 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.
3. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written
informed consent.
4. Patient is able to read, understand and complete questionnaires and diaries, including operation of the eDiary.
5. Patient has completed at least 6 years of formal education; patient obtains a score
6th grade level on Reading Subtest of Wide Range Achievement Test Version 4
(WRAT-4) at screening. For languages other than English, the SPONSOR will
specify other tests or methods of assessing. NOTE: Patients with any secondary
education (any formal education beyond 8th grade) do not need to conduct a reading
assessment.
6. Patient is in good physical and mental health in the opinion of the investigator.
7. Patient reports on at least 3 out of 7 nights each week during the 4 weeks prior to
Visit 1 each of the following:
7.1. Total sleep time of 6.5 hours;
7.2. Sleep latency of 30 minutes;
7.3. 1 hour of wakefulness after sleep onset; and
7.4. Spending 6.5 to 9 hours nightly in bed.
8. Patient is willing to stay overnight at a sleep laboratory.
9. Patient is willing to stay in bed for at least 8 hours each night while at the sleep
laboratory.
10. The patient’s regular bedtime is between 9 PM (21:00) and 12 AM (00:00).
11. During the study, the patient is willing to refrain from napping.
12. During the study, patient is willing to limit alcohol to 2 drinks a day, at least 3 hours before going to bed on non-PSG visit days, and refrains from drinking alcohol at least 24 hours prior to a PSG visit.
13. During the study, the patient is willing to limit caffeine consumption to 5 standard
6-ounce cups of caffeinated beverages a day, or 600 mg caffeine, avoid caffeine
after 4 PM (16:00) on non-PSG nights, and avoid caffeine after 1 PM (13:00) on PSG
visits.
14. A female patient who is of reproductive potential has a serum -hCG level consistent with the nongravid state at Screening Visit 1 and agrees to use acceptable contraception. Acceptable contraception is defined as abstinence (where abstinence is a locally accepted form of contraception) or use of 2 regionally accepted effective non-hormonal forms of contraception including: partner using condom with spermicide or status post vasectomy, and patient using intra-uterine device (IUD), diaphragm with spermicide, contraceptive sponge. Note that if a male partner does not use an effective form of contraception, a female patient MUST use 2 acceptable forms of contraception to satisfy the study requirement.
15. A female patient that is postmenopausal or status post hysterectomy, bilateral tubal ligation, or bilateral oophorectomy is eligible without requiring the use of
contraception. Postmenopausal status is defined as age 43 years and (1) no menses
for > 1 year but < 3 years and confirmed by FSH levels elevated into the
postmenopausal range, as defined by the designated laboratory, or (2) no menses for at least 3 years.
16. Patient has latency to persistent sleep (LPS) > 20 minutes during the Screening PSG at Visit 2.
17. Patient has WASO > 45 minutes during the Screening PSG at Visit 2.
18. Patient has LPS > 20
1. If female, patient is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.
2. Patient is expecting to donate eggs or sperm during the study or within 90 days of
their last dose of study medication.
3. Patient has a history or diagnosis of any of following conditions, in the opinion of the investigator:
3.1. Narcolepsy
3.2. Idiopathic cataplexy
3.3. Circadian rhythm sleep disorder
3.4. Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking
disorder, and REM behavior disorder
3.5. Sleep-related breathing disorder (such as central sleep apna syndromes,
obstructive sleep apnea syndromes, sleep-related hypoventilation/hypoxemic
syndrome, and other sleep-related breathing disorders)
3.6. Periodic limb movement disorder
3.7. Restless legs syndrome
3.8. Primary hypersomnia
3.9. Excessive daytime sleepiness (EDS) that is not attributable to primary insomnia
4. Patient has any history of a neurological disorder in the last 10 years.
5. Patient has history within the past 6 months prior to the Screening Visit or current
evidence of unstable or otherwise clinically significant cardiovascular disorder including:
5.1. acute coronary syndrome
5.2. unstable angina
5.3. congestive heart failure
5.4. cardiogenic syncope
5.5. cardiomyopathy
5.6. any symptomatic arrhythmia
6. Patient has clinically significant AV conduction disturbance, sick sinus syndrome, bradycardia, accessory bypass tract.
7. Patient has a history or current evidence of long QT syndrome, Torsades de pointe, or a QTcB interval of > 450.
8. Patient has a screening blood pressure > 150 mmHg systolic or > 90 mmHg diastolic or a pulse rate > 100 beats/min in a sitting position. Blood pressure and pulse measurements exceeding these limits, may be repeated as warranted by the investigator, but values must be within the specified limits for the patient to be eligible for the study.
9. Patient has any of the following:
9.1. A lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic
stress disorder;
9.2. A psychiatric condition requiring treatment with a prohibited medication; or
9.3. Other current psychiatric condition that, in the investigator’s opinion, would
interfere with the patient’s ability to participate in the study.
10. Patient has evidence of ongoing depression or suicidality.
11. Patient has a history of substance abuse or dependence.
12. Patient has a positive screening urine drug screen.
13. Patient has a history of malignancy 5 years prior to signing informed consent,
except for adequately treated basal cell or squamous cell skin cancer or in situ
cervical cancer.
14. Patient has a history of hypersensitivity or idiosyncratic reaction to more than two chemical classes of drugs, including prescriptions and over-the-counter medications.
15. Patient has a history or current evidence of any condition, therapy, lab or ECG abnormality, or other circumstances that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study.
16. Patient has abnormal screening laboratory values per the guidelines below or other clinically significant, unexplained laboratory abnormality:
Alanine transaminase (SGPT or ALT) > 1.5 times the upper limit of normal (x ULN)
Aspartate transaminase (SGOT or AST) > 1.5 x ULN
Total bilirubin > 1.5 x ULN
Serum creatinine of 2 mg/dL
17. Patient has a history of tran
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