EUCTR2005-004417-15-BE进行中（未招募）不适用
Single center, therapeutic exploratory clinical trial to evaluate the safety of sodium oxybate (Xyrem) 500 mg/mL oral solution on potential endocrine changes at currently labeled therapeutic dose regimens (4.5 g/day divided into two equal doses)during twelve weeks of treatment of cataplexy in adult patients with narcolepsy. - C00301
CB Pharma Ltd0 个研究点目标入组 25 人开始时间: 2006年4月4日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- •To be eligible to participate in this study, all of the following criteria must be met:
- •·Male or female subjects, aged from 18 to 65 years inclusive, from any racial group;
- •·Written informed consent dated and signed by the subject;
- •·The subject must have met criteria for a primary diagnosis of narcolepsy with cataplexy:
- •·Daytime sleepiness daily for at least 3 months
- •·Inadvertent naps / Sleep attacks
- •·Bilateral postural muscle weakness triggered by emotions;
- •·The subject must demonstrate an adequate need for cataplexy treatment, as determined by the Investigator, based on a review of the subject’s history and any relevant clinical findings. The subject must either have a need for, or have had an adequate response to standard treatment as determined by the treating physician;
- •·Female subjects without childbearing potential (2 years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they are sexually abstinent or if they use a medically accepted contraceptive method (hormonal contraception must be stable since at least 3 months before entry in the study and must be continued until the end of the study because of the influence on IGF-1 levels);
- •·Be considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must be excluded if they meet any of the following criteria:
- •·History or presence of cardiovascular, respiratory, hepatic/biliary, renal, gastrointestinal, endocrinological, neurological disorders capable of altering the absorption, distribution, metabolism or elimination of drugs, or constituting a possible risk factor when taking the study medication. A blood sampling and urinalysis taken within the 3 months preceding the screening or at screening must demonstrate there is no risk according to the investigator’s judgment to include the subject (see section 11.1.7);
- •·History of clinically significant hypersensitivity or allergy to sodium oxybate or to any of the excipients;
- •·History or presence of drug addiction (positive drug screen), or excessive use of alcohol (positive alcohol breath test);
- •·Patients with succinic semialdehyde dehydrogenase deficiency;
- •·Patients being treated with sedative hypnotics, other CNS depressants, corticoids (which are not taken at a stable dose for at least two months. No topical, intra-muscular or intra-venous formulation), opioids or barbiturates during one week (one month for enzyme-inducers) preceding the study drug administration;
- •·Participation in another clinical trial less than 3 months before the present study;
- •·Subjects who, in the judgment of the investigator, are likely to be non reliable or non-compliant or uncooperative during the study.
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