EUCTR2009-015565-31-FR进行中（未招募）1 期
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Long Term Safety Study of MK-4305 in Patients with Primary Insomnia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 964
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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.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. Of note, in the event that eDiaries are not available for a country, paper measures may be used at the SPONSOR’s discretion.
- •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.
- •6.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 old, answer YES except in cases where administration of the MMSE to the patient <65 seems indicated in the opinion of the investigator.
- •7.A female patient who is of reproductive potential has a serum ß-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.
- •8.Patient demonstrates compliance with the morning and evening diary for the period between Visit 2 and 3. Diary compliance is defined as patient having completed at least 70% [e.g. 5 out of 7 days/nights] of both the morning and evening diaries.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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 >
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