A Study of Dimdazenil in Patients With Parkinson's Disease and Insomnia

N/ANot Yet RecruitingNCT07714772

Second Affiliated Hospital of Soochow University50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Insomnia Parkinson's Disease (PD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 ≤3. * 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. Exclusion Criteria: * 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 ≥29. * 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).

Outcomes

Primary Outcomes

Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment

Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).

Time frame: Baseline, Night 14

Secondary Outcomes

Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 1 of dimdazenil treatment

Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).

Time frame: 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

Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) is the motor examination section of the MDS-UPDRS, used to assess the severity of motor symptoms in patients with Parkinson's disease. The MDS-UPDRS-III comprises 27 items across 14 categories, including facial expression, tremor, rigidity, bradykinesia, postural instability, and gait examination. Each item is scored on a 5-point Likert scale (ranging from 0 to 4), with a total score range of 0 to 108. Higher scores indicate more severe motor symptoms.

Time frame: baseline, Day 14

Change from baseline in latency to persistent sleep (LPS) measured by polysomnography (PSG)

Latency to persistent sleep (LPS) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG), defined as the time from the start of PSG recording to the onset of non-rapid eye movement (NREM) sleep stage 1。

Time frame: baseline, Night 1，Night 14

Change from baseline in wake after sleep onset (WASO) measured by polysomnography (PSG)

Central Contacts

Xy Cheng

CONTACT

0086 0512-67784179 chengxiaoyu2007@126.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Wake after sleep onset（WASO） is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG)。Polysomnography (PSG) is a medical device that comprehensively evaluates sleep quality by simultaneously recording more than 10 physiological parameters, including electroencephalography (EEG)。PSG is regarded as the "gold standard" for the diagnosis of sleep disorders.

Time frame: baseline, Night 1，Night 14

Change from baseline in number of awakenings (NAW) measured by polysomnography (PSG)

Number of awakenings (NAW) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).

Time frame: baseline, Night 1，Night 14

Change from baseline in sleep efficiency (SE) measured by polysomnography (PSG)

Sleep efficiency (SE) is calculated from the total sleep time (TST) and total time in bed (TIB) recorded automatically by PSG, with the formula: SE = TST / TIB × 100%. Total sleep time (TST): The sum of the durations of all epochs scored as N1, N2, N3, and REM sleep in the PSG recording, excluding all epochs scored as "Wake". Total time in bed (TIB): The total duration from the start of PSG recording (when the subject goes to bed and prepares to sleep) to the end of recording (when the subject gets out of bed and leaves).

Time frame: baseline, Night 1，Night 14

Change from baseline in subjective total sleep time (sTST)

subjective total sleep time (sTST) is recorded in sleep diary

Time frame: baseline, Day 14 under the treatment of dimdazenil

Change from baseline in subjective sleep onset latency (sSL)

sSL is recorded in sleep diary

Time frame: baseline, Day 14 under the treatment of dimdazenil

Change from baseline in subjective wake after sleep onset (sWASO)

sWASO is recorded in sleep diary

Time frame: baseline, Day 14 under the treatment of dimdazenil

Change from baseline in subjective number of awakenings (sNAW)

sNAW is recorded in sleep diary

Time frame: baseline, Day 14 under the treatment of dimdazenil

Change from baseline in subjective sleep efficiency (sSE)

Subjective sleep efficiency (sSE) is calculated from the subjective total sleep time (sTST) and total time in bed (TIB) recorded by the subject via a sleep diary, using the formula: sSE = sTST / TIB × 100%. Total time in bed (TIB): The total duration recorded by the subject from the time they go to bed and attempt to sleep to the time they get out of bed the next morning. Subjective total sleep time (sTST): The total sleep duration calculated by subtracting sleep latency (time to fall asleep) and wake after sleep onset (WASO) from the total time in bed (TIB).

Time frame: baseline, Day 14 under the treatment of dimdazenil

Change from baseline in Insomnia Severity Index (ISI) total score

The Insomnia Severity Index (ISI) is a self-reported questionnaire used to assess the severity of insomnia in subjects. The ISI comprises 7 items grouped under 5 major domains. The total score is the sum of each individual item score, ranging from 0 to 28. Scores are interpreted as follows: 0-7: no clinically significant insomnia; 8-14: subthreshold insomnia; 15-21: clinical insomnia (moderate); 22-28: clinical insomnia (severe).

Time frame: baseline, Day 14 under the treatment of dimdazenil

Changes from baseline in the Parkinson's Disease Sleep Scale (PDSS) total score and individual item scores after 14 days of dimdazenil treatment

The Parkinson's Disease Sleep Scale (PDSS) is a 15-item self-reported instrument specifically designed to evaluate nocturnal sleep disturbances and daytime functioning in patients with Parkinson's disease. Each item is scored from 0 to 10 (0 = extremely severe symptoms, 10 = no symptoms), with a total score ranging from 0 to 150. Higher scores indicate better sleep quality.

Time frame: baseline, Day 14

PSG-recorded sleep time duration in NREM sleep stages 1（N1）

Sleep time duration in Non-rapid eye movement(NREM) sleep stages 1（N1） is derived from automatic recordings obtained via polysomnography (PSG).