Primary Insomnia MedDRA version: 12.0 Level: LLT Classification code 10036701 Term: Primary insomnia
Conditions
Interventions
Product Name: MK-4305
Product Code: MK-4305
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the p
Sponsors
Merck Sharp & Dohme (Sweden) AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is male or female and =18 years of age on the day of signing informed consent. 2. Patient has a DSM-IV-TR (Appendix 6.2) 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. For a patient =65 years of age, (s)he scores =25 on the Mini Mental State Examination (MMSE), to rule out cognitive impairment in the interest of safety for the patient. NOTE: If =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has a recent and/or active history of a confounding 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 and residual impairment within the last 10 years. 2. Patient has either a history within the past 6 months prior to the Screening Visit 1 or current evidence of an unstable or otherwise clinically significant cardiovascular disorder, including but not limited to: acute coronary syndrome unstable angina, congestive heart failure cardiogenic syncope cardiomyopathy any symptomatic arrhythmia 3. Patient has abnormal screening laboratory values per the guidelines below, or in the opinion of the investigator has any other clinically significant 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 4. Patient is taking, or plans to take, one or more of the following medications (non-inclusive), shown below, within the specified washout periods prior to Screening Visit 2 and throughout the course of the study: Investigational compounds-4 weeks or 5 t½ lives (which ever is longer) Clinically relevant CYP3A4 Inhibitors and Inducers-2 weeks or 5 t½ lives (which ever is longer) Centrally acting anticholinergics or antihistamines-2 weeks Melatonin-2 weeks Anticonvulsants-2 weeks Antipsychotics-2 weeks Anxiolytics-2 weeks Benzodiazepines-2 weeks or 5 t½ lives (which ever is longer) Hypnotics-2 weeks or 5 t½ lives (which ever is longer) Any CNS depressants-2 weeks Over-the-counter medications that could affect sleep [e.g., kava-kava, valerian, Benadryl (diphenhydramine) St. Johns wort] -2 weeks Stimulants-2 weeks Diet pills-2 weeks 5. Patient has any of the following: a. A lifetime history of bipolar disorder, a psychotic disorder, or posttraumatic stress disorder; b. A psychiatric condition requiring treatment with a prohibited medication; or c. Other current psychiatric condition that, in the investigator's opinion, would interfere with the patient's ability to participate in the study. 6. Patient has evidence of suicidality (based on a score of = 2 on the QIDS-SR16 suicide item #12) or, in the investigator's opinion, is otherwise 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). 7. Patient, in the opinion of the Investigator, has difficulty sleeping due to tobacco, caffeine, or alcohol use. 8. 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. 9. Patient has a history of transmeridian travel (across > 3 time zones or > 3 hour time difference) within the past 2 weeks. 10. Patient has a history of shift work (defined as permanent night shift or rotating day/night shift work) within the past 2 weeks or anticipates need to perform shift work during the study. 11. Patient has a history or diagnosis of any of following conditions, in the opinion of the investigator: a. Narcolepsy b. Cataplexy (familial or idiopathic) c. Circadian Rhythm Sleep Disorder d. Parasomnia including nightmare disorder, sleep terror disorder, sleepwalking disorder, and R
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of of MK-4305 for up to 12 months of treatment.;Secondary Objective: 1. To evaluate the efficacy of MK-4305 compared with placebo in improving insomnia, as measured by change from baseline in subjective total sleep time (sTST) on the sleep diary during the first month of treatment (using the average of weekly measurements [Weeks 1, 2, 3 and 4]). 2. To evaluate the efficacy of MK-4305 compared with placebo in improving insomnia, as measured by change from baseline in subjective time to sleep onset (sTSO) on the sleep diary during the first month of treatment. ;Primary end point(s): • adverse experiences (AEs), • laboratory values, • ECGs, • physical examinations, • vital signs, • rebound insomnia and withdrawal effects. • The Columbia - Classification Algorithm of Suicide Assessment (C-CASA) scores from the C-SSRS will also be evaluated | — |
Countries
Belgium, Denmark, Finland, France, Germany, Hungary, Spain, Sweden, United Kingdom
Outcome results
None listed