EUCTR2013-001506-29-IT进行中（未招募）1 期
Double blind, multicentre, randomized, placebo-controlled trial to evaluate safety and efficacy of pitolisant in children from 6 to less than 18 years with narcolepsy with/without cataplexy, followed by a prolonged open-label period. - P11-06
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
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)Male and female children from 6 to less than 18 years of age (until V8) suffering from narcolepsy with or without cataplexy - meeting the International Classification of Sleep Disorders (ICSD-3) criteria (narcolepsy type 1 and 2). Diagnosis confirmed with polysomnography and Multiple Sleep Latency Test for patients without cataplexy (if these examinations were not performed within the last 12 months)
- •2)PDSS score = 15 during baseline period (V1+V2) / 2.
- •3)Patients should be free of non-authorized medication, in particular psychostimulant treatments as from the screening visit (V0) onwards.
- •4)Parents – and patients old enough to understand who have expressed a willingness to participate in the study, who have signed and dated the informed consent form prior to beginning protocol required procedures.
- •5)In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests).
- •6)Female pubescent patients shall use a birth control method, judged efficient by the investigator, throughout the study and during the month following treatment discontinuation.
- •7)Patients should benefit from appropriate healthy insurance system (only applicable where mandatory e.g. in France).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1)Any other conditions that can be considered the primary causes of EDS: such as sleep related breathing disorders as defined by a sleep Apnea Index = 5 per hour or/and an Apnea/Hypopnea Index = 10 per hour, chronic sleep deprivation, circadian sleep wake rhythm disorder or any other medical or neurological causes that could account for narcolepsy symptoms associated with EDS.
- •2)Cataplectic patients treated by anticataplectics (SNRI, SSRI, sodium oxybate) which are not under a stable treatment since at least 4 weeks at the time of inclusion (V2).
- •3)Patients treated for cataplexy or any other pathology, by tricyclic antidepressants (clomipramine, imipramine, mirtazapine, desmethylimipramine and protriptyline) are not authorized because they display histamine H1 receptor antagonist activity.
- •4)The use of pitolisant within a 30-day period prior to initial screening visit (V0) for this trial.
- •5)Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- •6)Any significant abnormality of the electrocardiogram and particularly Fridericia’s QTc interval (QTcF = QT/3¿ 60/HR) higher than 450ms.
- •7)Patients with severe depression (CDI = 16)
- •8)Patient with suicidal risk (C-SSRS)
- •9)Positive urinary drug testing (test applicable to patients from 12 years)
- •10)Pregnancy (defined as positive ß-HCG blood test), breast-feeding, or patients and unable to use an efficient method of birth control shall not be included in the study (for pubescent female only).
- •11)Patients with severe hepatic Impairment (Child Pugh C) or with any other significant abnormality in the physical examination or clinical laboratory results.
- •12)Psychiatric and neurological disorders, such as moderate or severe psychosis or dementia, depression, history of seizure disorder or other problem that, in the investigator’s opinion, would preclude the patient’s participation and completion of this trial or comprise reliable representation of subjective symptoms.
- •13)Active clinically significant illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, haematological, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study objectives.
- •14)Prior severe adverse reactions to CNS stimulants.
- •15)Known hypersensitivity to the tested treatment including active substance and excipients.
- •16)The inability to continue daily activities safely, without the use of treatment against EDS.
- •17)Any patient presenting congenital galactosemia, glucose-galactose malabsorption or lactase deficiency due to the presence of lactose in investigational treatments.
- •18)Patients participating in another study or being in a follow–up period for another study.
- •19)Cannot be contacted in case of emergency.
研究者
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