2024-519466-44-00招募中3 期
A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy with Cataplexy (Narcolepsy Type 1)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Time to loss of responsea in the Epworth Sleepiness Scale (ESS) score during the up to 4-week RW period.
研究概览
简要总结
To assess the maintenance of effect of TAK-861 as measured by the loss of response criteria.
研究设计
- 分配方式
- Randomized
- 主要目的
- A Randomized Withdrawal Trial Of Tak-861 For The Treatment Of Narcolepsy With Cataplexy
- 盲法
- Double (Subject, Carer, Investigator, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
- •The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form [ICF]) and any required privacy authorization before the initiation of any trial procedures.
- •The participant is aged 18 to 70 years, inclusive, at the time of signing the ICF.
- •The participant has a body mass index within the range 18 to 40 kg/m² at screening (inclusive).
- •The participant has an ICSD-3 or ICSD-3-TR diagnosis of NT1 supported by results from 1) polysomnography [PSG] (with or without multiple sleep latency test [MSLT]), and meeting the minimal acceptable criteria for the proper performance of PSG/MSLT as outlined in the ICSD-3 or ICSD-3-TR or 2) CSF test indicating an OX/hypocretin-1 concentration of ≤110 pg/mL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
- •The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 (positive results for either homozygous or heterozygous alleles will be considered “positive” and acceptable) or results from radioimmunoassay indicate the participant’s CSF OX/hypocretin-1 concentration is ≤110 pg/mL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
- •The participant is judged by the investigator to be sufficiently healthy to participate in the trial, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiography (ECG), and vital sign measurements performed at the screening visit and before the first dose of trial intervention.
- •The participant agrees to follow the birth control requirements detailed in the protocol.
排除标准
- •The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
- •The participant has a known hypersensitivity to any component of the formulation of TAK-861 or related compounds.
- •The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
- •The participant is unable to refrain from or anticipates using excluded food products, or prohibited medications as described in the protocol.
- •The participant has participated in another investigational drug trial, in which they received the investigational drug. The interval window from the previous trial will be derived from the date of the last dose of investigational drug in the previous trial to the screening visit of the current trial. The participant must agree not to participate in any other interventional trial while participating in TAK-861-
- •The participant has a resting heart rate [as per protocol] during screening, confirmed on repeat testing [as per protocol].
- •The participant’s screening ECG reveals a QT interval with Fridericia correction method [as per protocol] (genetically male) or [as per protocol] (genetically female).
- •The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus antibody/antigen at screening.
- •The participant has a positive pregnancy test at screening or Day -2 or is breastfeeding.
- •The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year before screening or has positive answers on Item number 4 or 5 on the Columbia Suicide Severity Rating Scale performed prior to enrollment (Day -2).
- •The participant is a trial site employee or an immediate family member of or in a dependent relationship with a trial site employee (for example, spouse, parent, child, or sibling) who is involved in the conduct of this trial or may consent under duress.
- •The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure, or c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease.
- •The participant consumes excessive amounts of caffeine, [as] defined [per protocol]. (1 cup of coffee is approximately 120 mg.)
- •The participant currently consumes alcohol exceeding [as defined per protocol] on average (1 standard drink is approximately equivalent to the following: beer [354 mL/12 oz], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).
- •The participant has a nicotine dependence that is likely to affect sleep (for example, a participant who routinely awakens at night to smoke).
- •The participant has a usual bedtime later than 12 AM (midnight), an occupation requiring night-time shift work or variable shift work within the past 6 months, travel with significant jet lag within 14 days before Day -2 or plans for travel with significant jet lag.
- •The participant, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
- •The participant is considered to be vulnerable, as defined by local regulations and if exclusion is required by local regulations. Examples of vulnerable persons are persons under safeguard of justice, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care without their consent, persons admitted to a health or social establishment for purposes other than research, persons of full age who are subject to a legal protection measure (guardianship or curatorship), and persons unable to express their consent.
- •The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- •The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the sponsor or designee).
- •The participant has a clinically significant history of head injury or head trauma.
- •The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
- •The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
- •The participant has 1 or more of psychiatric disorders: c) Current active major depressive episode (MDE) or an active MDE in the past 6 months. d) Any current unstable psychiatric disorder
- •The participant has a current history of significant multiple or severe allergies (for example, food, drug, or latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
结局指标
主要结局
Time to loss of responsea in the Epworth Sleepiness Scale (ESS) score during the up to 4-week RW period.
Time to loss of responsea in the Epworth Sleepiness Scale (ESS) score during the up to 4-week RW period.
次要结局
- 01. Change from the end of the Open-Label (OL) Treatment Period to Week 2 of the RW period in mean sleep latency on the MWT.
- 02. WCR at Week 2 of the RW period.
- 03. Change from the end of the OL treatment period to Week 2 of the RW period in number of lapses on the PVT.
- 04. Occurrence of reporting much or very much worse in PGI-C score at Week 2 of the RW period.
- 05. Change from the end of the OL treatment period to Week 2 of the RW period in NSS-CT total score.
- 06. Change from the end of the OL treatment period to Week 2 of the RW period in FINI domain scores for: tiredness, cognitive functioning, cataplexy, social activities, everyday activities, and everyday responsibilities.
- 07. Change from the end of the OL treatment period to Week 2 of the RW period in number of correct responses on the iDSST-s.
- 08. Occurrence of at least 1 TEAE during the OL treatment period and the RW period including the follow-up period, as applicable.
研究者
Rebecca Wu
Scientific
Takeda Development Center Americas Inc.
研究点 (2)
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