NL-OMON43610已完成3 期
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallelgroup, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2- amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy - TONES-002
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
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
- •1. Males and females between 18 and 75 years of age, inclusive.
- •2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria.
- •3. Baseline mean sleep latency *25 minutes as documented by the mean of the first four trials of the
- •Baseline 5-trial MWT.
- •4. Baseline Epworth Sleepiness Scale (ESS) score *10.
- •5. Usual nightly total sleep time of at least 6 hours.
- •6. Body mass index from 18 to <45 kg/m2 .
- •7. Consent to use a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug, throughout the entire study period, and for 30 days after the study is completed.
- •8. Willing and able to comply with the study design schedule and other requirements.
- •9. Willing and able to provide written informed consent.
排除标准
- •1. Female subjects who are pregnant, nursing, or lactating.
- •2. Usual bedtime later than 1 AM (0100 hours).
- •3. Occupation requiring nighttime or variable shift work.
- •4. Moderate or severe obstructive sleep apnea (OSA) on the baseline PSG.
- •5. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness.
- •6. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria.
- •7. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator.
- •8. History of bariatric surgery within the past year or a history of any gastric bypass procedure..
- •9. Presence of renal impairment or calculated creatinine clearance <60 mL/min.
- •10. Clinically significant ECG abnormality, in the opinion of the Investigator.
- •11. This criteria has been removed.
- •12. Presence of significant cardiovascular disease including but not limited to: myocardial infarction within the past year, unstable angina pectoris, symptomatic congestive heart failure (ACC/AHA stage C or D), revascularization procedures within the past year, ventricular cardiac arrhythmias requiring automatic implantable cardioverter defibrillatory (AICD) or medication therapy, uncontrolled hypertension, systolic blood pressure *155 mmHg or diastolic blood pressure *95 mmHg (at screening, or consistently across Baseline measures according to protocol specifications), or any history of cardiovascular disease or any significant cardiovascular condition that in the investigator's opinion may jeopardize subject safety in the study.
- •13. Laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, and urinalysis); NOTE: Screening labs may be repeated once.
- •14. Excessive caffeine use one week prior to Baseline assessments or anticipated excessive use during the study defined as >600 mg/day of caffeine.
- •15. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of
- •excessive sleepiness within a time period prior to the Baseline visit corresponding to at least five half-lives of the drug(s) or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded medications include OTC sleep aids or
- •stimulants (e.g., pseudoephedrine), methylphenidate, amphetamines, modafinil, armodafinil, sodium
- •oxybate, pemoline, trazodone, hypnotics, benzodiazepines, barbiturates, and opioids. Medications should be discontinued such that the subject has returned to his/her baseline level of daytime sleepiness at least 7 days prior to the Baseline visit, in the opinion of the Investigator.
- •16. Use of any medications that could affect the evaluation of cataplexy within a time period prior to the Baseline visit corresponding to at least five half-lives of the drug(s) or planned use of such drug(s) at some point throughout the duration of the study. Examples of excluded anti-cataplectic medications include selective serotonin reuptake
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