jRCT2031240163招募中不适用
A phase II/III study of NPC-22 in patients with chronic sialorrhea (NPC-22-5)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 主要终点
- Change from baseline in salivary flow rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •(1) Patients who can provide their own informed consent, fulfill comply with their responsibility as study participants, undergo a medical examination and test specified in the protocol, and report their condition, etc.
- •(2) Male or female patients aged=>18 and <=80 years at the time of informed consent
- •(3) Patients with sialorrhea (Sialorrhea Scoring Scale [SSS] of =>5)
- •(4) Group A:
- •<ALS> Patients who meet eitherhave definite or probable ALS according to the El Escorial and the revised Airlie House
- •diagnostic criteria
- •<PD> Patients diagnosed with clinically probable Parkinson's disease according to MDS clinical diagnostic criteria
- •<Patients with chronic sialorrhea excluding ALS and PD>
- •Patients who have a disease that causes sialorrhea
- •Examples: Clinically diagnosed progressive supranuclear palsy, spinocerebellar degeneration, multiple system atrophy,
- •corticobasal degeneration, stroke, traumatic brain injury, etc.
排除标准
- •<Exclusion criteria applicable to Group A and Group B>
- •(1) Patients who need to use prohibited concomitant drugs, including anticholinergic drugs or tricyclic antidepressants, or
- •undergo prohibited concomitant therapy from 28 days before the start of investigational product administration through the
- •end of the follow-up period
- •(2) Patients who have received an injection of botulinum toxin within 16 weeks before the start of investigational product
- •administration (within one year for sialorrhea)
- •(3) Patients with angle closure glaucoma, open-angle glaucoma, or dysuria caused by prostatic hypertrophy or those with serious
- •heart disease, congestive heart failure, arrhythmia, paralytic ileus, ileus, ulcerative colitis, asthma, hyperthyroidism, epilepsy,
- •hepatitis, or other conditions that are disqualified from participation in the study by the investigator or sub-investigator
- •(4) Patients withypersensitivity to patches
- •(5) Patients with or with a history of skin diseases or abnormalities at the site of investigational product administration that
- •interfere with evaluation and those who are receiving treatment at the site of investigational product administration that
- •interfere with evaluation (such as topical corticosteroids)
- •(6) Patients in whom it is difficult to measure salivary flow rate
- •(7) Patients who have marked dental or intraoral lesions
- •(8) Patients whose dental or oral hygiene is extremely poor and may hinder safe participation in the study in the opinion of the
- •investigator or sub-investigator
- •(9) Patients who have dementia or an MMSE-J score of <=23
- •<Exclusion criteria only applicable to Group A>
- •(10) Patients with sialorrhea not caused by ALS or PD
- •(11) Patients who need to change therapeutics for ALS or anti-PD drugs, change the method of using restricted concomitant
- •therapy, or undergo new restricted concomitant therapy for the period from 28 days before the start of investigational product
- •administration to the end of the double-blind period
结局指标
主要结局
Change from baseline in salivary flow rate
时间窗: four weeks after the start of treatment
Change from baseline (at the start of the double-blind period) in salivary flow rate
次要结局
未报告次要终点
研究者
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