NCT07714772尚未招募不适用
Efficacy and Safety of Dimdazenil, a GABAA Receptor Partial Agonist, in the Treatment of Insomnia in Patients With Parkinson's Disease
Second Affiliated Hospital of Soochow University0 个研究点目标入组 50 人开始时间: 2026年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment
研究概览
简要总结
This study will use sleep parameters measured by polysomnography (PSG) as the primary means to evaluate the efficacy and safety of dimdazenil, a GABAA receptor partial agonist, in treating insomnia in Parkinson's disease patients.
详细描述
This study will enroll a total of 50 Parkinson's disease patients with insomnia, aged ≥18 years. Eligible subjects who meet the inclusion and exclusion criteria and are judged by the investigator to be suitable for the study drug will receive dimdazenil capsules at a dose of 2.5 mg per night, with a total treatment duration of 14 days，taken orally immediately before bedtime as prescribed.
The primary efficacy endpoint is the change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14. Secondary endpoints include multiple objective and subjective sleep parameters derived from PSG and sleep diaries, daytime function assessed by validated scales, and Parkinson's disease symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent voluntarily after full comprehension of the study.
- •Be aged ≥18 years, male or female.
- •Meet the diagnostic criteria for Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), with a modified Hoehn-Yahr stage ≤
- •Have insomnia symptoms [reduced total sleep time (<6.5 h) and/or sleep-onset latency >30 min, and/or ≥2 nocturnal awakenings, early-morning awakening, or poor sleep quality], occurring at least three times per week, accompanied by daytime dysfunction or daytime distress, with adequate opportunity for sleep yet difficulty initiating or maintaining sleep, and that cannot be fully explained by another sleep-wake disorder; and have satisfactory control of Parkinson's disease motor symptoms [MDS-UPDRS Part III (ON state) score ≤30].
- •Be on a stable anti-Parkinsonian medication regimen, defined as no change in the type, dosage, or frequency of anti-Parkinsonian drugs for at least 4 weeks prior to enrollment, with no motor fluctuations or dyskinesia.
- •Have a clinical decision by the attending physician to initiate didazinin treatment per routine practice.
- •Be able to undergo polysomnography (PSG) monitoring.
- •Be conscious, capable of normal communication, and able to complete sleep diaries independently.
排除标准
- •Have Parkinson-plus syndromes, secondary parkinsonism, or other non-idiopathic Parkinson's disease.
- •Have used benzodiazepine sedative-hypnotics within 7 days prior to enrollment.
- •Have other significant comorbidities, such as malignant tumors, or clinically significant impairment of cardiac, hepatic, or renal function.
- •Have severe obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), respiratory insufficiency, or myasthenia gravis.
- •Have known hypersensitivity to any component of didazinin.
- •Have moderate-to-severe depression or anxiety, defined as a Hamilton Depression Rating Scale (HAMD) score ≥25 or a Hamilton Anxiety Rating Scale (HAMA) score ≥
- •Have a history of substance abuse (e.g., drug addiction or alcohol dependence).
- •Have a history of epilepsy, schizophrenia, bipolar disorder, developmental delay, or cognitive impairment.
- •Be pregnant or breastfeeding.
- •Be unwilling or unable to comply with scheduled follow-up visits.
- •Have any other condition that, in the investigator's judgment, would make the subject unsuitable for participation (e.g., anticipated inability to complete follow-up within 14 days, or concurrent use of other medications that may substantially interfere with sleep assessment and cannot be withdrawn).
结局指标
主要结局
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment
时间窗: Baseline, Night 14
Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
次要结局
- Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 1 of dimdazenil treatment(baseline, Night 1)
- Change from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score after 14 days of dimdazenil treatment(baseline, Day 14)
- Change from baseline in subjective sleep onset latency (sSL)(baseline, Day 14 under the treatment of dimdazenil)
- Change from baseline in latency to persistent sleep (LPS) measured by polysomnography (PSG)(baseline, Night 1，Night 14)
- Change from baseline in wake after sleep onset (WASO) measured by polysomnography (PSG)(baseline, Night 1，Night 14)
- Change from baseline in number of awakenings (NAW) measured by polysomnography (PSG)(baseline, Night 1，Night 14)
- Change from baseline in sleep efficiency (SE) measured by polysomnography (PSG)(baseline, Night 1，Night 14)
- Change from baseline in subjective total sleep time (sTST)(baseline, Day 14 under the treatment of dimdazenil)
- Change from baseline in subjective wake after sleep onset (sWASO)(baseline, Day 14 under the treatment of dimdazenil)
- Change from baseline in subjective number of awakenings (sNAW)(baseline, Day 14 under the treatment of dimdazenil)
- Change from baseline in subjective sleep efficiency (sSE)(baseline, Day 14 under the treatment of dimdazenil)
- Change from baseline in Insomnia Severity Index (ISI) total score(baseline, Day 14 under the treatment of dimdazenil)
- PSG-recorded sleep latency for N1 sleep(baseline, Night 1, Night 14)
- Changes from baseline in the Parkinson's Disease Sleep Scale (PDSS) total score and individual item scores after 14 days of dimdazenil treatment(baseline, Day 14)
- PSG-recorded sleep time duration in NREM sleep stages 1（N1）(baseline, Night 1, Night 14)
- PSG-recorded sleep time duration in NREM sleep stages 2（N2）(baseline, Night 1, Night 14)
- PSG-recorded sleep time duration in NREM sleep stages 3（N3）(baseline, Night 1, Night 14)
- PSG-recorded sleep time duration in REM sleep(baseline, Night 1, Night 14)
- PSG-recorded sleep latency for N2 sleep(baseline, Night 1, Night 14)
- PSG-recorded sleep latency for N3 sleep(baseline, Night 1, Night 14)
- PSG-recorded sleep latency for REM sleep(baseline, Night 1, Night 14)
- the percentage of total sleep time accounted for by N1 sleep(baseline, Night 1, Night 14)
- the percentage of total sleep time accounted for by N2 sleep(baseline, Night 1, Night 14)
- the percentage of total sleep time accounted for by N3 sleep(baseline, Night 1, Night 14)
- the percentage of total sleep time accounted for by REM sleep(baseline, Night 1, Night 14)
- Fatigue assessment after 14 days of dimdazenil treatment(baseline, Day 14)
- Daytime sleepiness assessment after 14 days of dimdazenil treatment(baseline, Day 14)
- Attention and working memory assessment after 14 days of dimdazenil treatment(baseline, Day 14)
- Cognitive function assessment after 14 days of dimdazenil treatment(baseline, Day 14)
- Incidence of adverse events during dimdazenil treatment(From date of signing the informed consent until the date of the end of study visit or early withdrawal, assessed up to 14 days)
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