EUCTR2009-015565-31-BE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. - Safety Study of MK-4305 in Patients with Primary Insomnia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
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
- 性别
- All
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. If female, patient is pregnant (positive serum pregnancy test at prestudy), breastfeeding, or expecting to conceive within the projected duration of the study. NOTE: If male, answer NO”.
- •2. Patient is expecting to donate egg or sperm during the study.
- •3. Patient has a history of hypersensitivity or idiosyncratic reaction to more than two (2) chemical classes of drugs, including prescriptions and over-the-counter medications.
- •4. Patient, in the opinion of the investigator, 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, such that it is not in the best interest of the patient to participate. Examples of excluded disorders include, but are not limited to: HIV or other relevant infections, history of acute or chronic hepatitis, history of gastric bypass or gastric banding surgery, uncontrolled hypertension, or active endocrine disorders (however, patients with well-controlled insulin-dependent diabetes, type II diabetes, or hypothyroidism are allowed if on stable doses of appropriate therapy for =1 month prior to Screening Visit 2).
- •5. 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.
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