NL-OMON53057已完成3 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/Pitolisant
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bioprojet
- 入组人数
- 10
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
- 2 至 17（—）
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).
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 β-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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