Primary insomnia MedDRA version: 12.0 Level: LLT Classification code 10036701 Term: Primary insomnia
Conditions
Interventions
Product Name: MK-6096
Pharmaceutical Form: Tablet
Other descriptive name: L-002061532, [(2R,5R)-5-(5-Fluoropyridin-
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Merck & Co. Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female between 18 and 1 year but 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland, Germany, Spain, United Kingdom
Outcome results
None listed