PER-145-09已完成未知
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
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The patient is a man or woman> 18 years of age on the day of signing the informed consent.
- •The patient has a diagnosis of Primary Insomnia according to the DSM-IV-TR (Appendix 6.2) according to the investigator´s criteria and the patient´s sleep history, as assessed in the Diagnostic Sleep Interview / Sleep History.
- •The patient understands the study procedures, the available alternative treatments, and the risks involved in the study, and voluntarily agrees to participate by providing written informed consent.
- •The patient is able to read, understand and fill out questionnaires and diaries, including the operation of the electronic journal. It should be noted that, in case electronic journals are not available in a country, paper measures may be used at the SPONSOR´s discretion.
- •The patient has completed at least 6 years of formal education; the patient obtains a score> 6 grade level in the Reading Subtest of the Wide Range Achievement Test, Version 4 (WRAT-4) in the selection. In the case of languages other than English, the SPONSOR shall specify other tests or evaluation methods.
- •In the case of a patient> 65 years of age, he (she) reaches a score> 25 on the Mini Mental State Examination (MMSE), to rule out a cognitive disorder for the safety of the ) patient. NOTE: If <65 years of age, answer YES, except in cases where, in the opinion of the investigator, the administration of MMSE to a patient <65 years of age is indicated.
- •A potentially fertile female patient has a serum b-hCG level consistent with the ungravious state on Visit 1 of the National Team and agrees to use acceptable contraceptive methods. Acceptable contraceptive methods means abstinence (in places where abstinence is considered a locally accepted contraceptive method) or the use of 2 regionally accepted effective non-hormonal contraceptive methods such as: use of condoms with spermicide or post-vasectomy status by part of the couple, and use of an intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge by the patient. Note that if the male partner does not use an effective contraceptive method, a female patient MUST use 2 acceptable contraceptive methods to meet the study requirement.
- •The patient continues to meet all the inclusion criteria of the Pre-Study.
- •The patient continues to meet all the inclusion criteria of the Pre-Study.
- •The patient demonstrates compliance with the morning and evening diary for the period between Visit 2 and 3. Compliance with the electronic journal is defined as a patient who has filled at least 70% [for example, 5 of 7 days / nights] of the morning and evening newspapers.
排除标准
- •In the case of women, the patient is pregnant (serum pregnancy test with positive result in the pre-study), is breastfeeding, or hopes to conceive within the projected duration of the study. NOTE: In the case of men, answer NO.
- •The / The patient is waiting to donate eggs or sperm during the study.
- •The patient has a history of hypersensitivity or idiosyncratic reaction to more than two (2) chemical classes of drugs, including prescription and non-prescription drugs.
- •The patient, in the opinion of the investigator, has a history or current evidence of any condition, therapy, laboratory or ECG abnormality, or other circumstances that could confuse the results of the study, or interfere with the patient´s participation throughout the study, not being the most convenient for the patient to participate in it. Examples of excluded disorders include, without limitation: HIV or other relevant infections, history of acute or chronic hepatitis, history of gastric bypass surgery or gastric band, uncontrolled hypertension, or active endocrine disorders (however, patients with insulin-dependent diabetes , well-controlled type II diabetes or hypothyroidism can participate if they receive stable doses of adequate therapy for> 1 month before Selection Visit 2).
- •The patient has a recent and / or active history of a neurological disorder that causes confusion, including, without limitation: seizure disorder (different from single episodes of childhood febrile seizures), stroke, transient ischemic accident, multiple sclerosis, cognitive disorder , or significant head trauma with prolonged loss of consciousness and residual disability within the last 10 years.
- •The patient has a history within the last 6 months before Visit 1 of the Selection or current evidence of an unstable or otherwise clinically significant cardiovascular disorder.
- •The patient on Visit 1 of the Selection has a clinically significant ECG abnormality such as AV conduction disorder (for example, second or third degree AV block), sick sinus syndrome, bradycardia, accessory bypass tract (for example, Wolff-Parkinson-White), or current evidence of long QT syndrome or Torsades de pointe.
- •The patient has abnormal laboratory values of selection
- •The patient has evidence of suicide (according to a score> 2 at point # 12 of suicide according to QIDS-SR16) or, in the opinion of the investigator, is otherwise affected in such a way that he cannot perform the procedures of the study in a safe and appropriate way (regardless of the QIDS-SR16 score).
- •The patient has a history of substance abuse or dependence (unless he is currently in full permanent remission for at least one year or meets the criteria for full early remission, in accordance with DSM-IV-TR). Substances are alcohol, marijuana, hypnotics, other prescription drugs, and illegal drugs, but nicotine dependence is excluded. A patient who meets the DSM-IV-TR criteria for permanent remission may be included if he / she, in the opinion of the investigator, has a low risk of suffering from subsequent dependence or drug abuse.
- •The patient, in the opinion of the Researcher, has difficulty sleeping due to the consumption of tobacco, caffeine or alcohol.
- •The patient has a history of malignancy <5 years before the signing of informed consent, except for basal cell or squamous cell cancer or cervical cancer in situ properly treated.
- •The patient has a history of
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