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

Official title

Efficacy and Safety of Dimdazenil, a GABAA Receptor Partial Agonist, in the Treatment of Insomnia in Patients With Parkinson's Disease

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.

Detailed description

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.

Primary outcome measures

• Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment [Time frame: Baseline, Night 14]

Secondary outcome measures (12)

• Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 1 of dimdazenil treatment [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 [Time frame: baseline, Day 14]
• Change from baseline in latency to persistent sleep (LPS) measured by polysomnography (PSG) [Time frame: baseline, Night 1，Night 14]
• Change from baseline in wake after sleep onset (WASO) measured by polysomnography (PSG) [Time frame: baseline, Night 1，Night 14]
• Change from baseline in number of awakenings (NAW) measured by polysomnography (PSG) [Time frame: baseline, Night 1，Night 14]
• Change from baseline in sleep efficiency (SE) measured by polysomnography (PSG) [Time frame: baseline, Night 1，Night 14]
• Change from baseline in subjective total sleep time (sTST) [Time frame: baseline, Day 14 under the treatment of dimdazenil]
• Change from baseline in subjective sleep onset latency (sSL) [Time frame: baseline, Day 14 under the treatment of dimdazenil]
• Change from baseline in subjective wake after sleep onset (sWASO) [Time frame: baseline, Day 14 under the treatment of dimdazenil]
• Change from baseline in subjective number of awakenings (sNAW) [Time frame: baseline, Day 14 under the treatment of dimdazenil]
• Change from baseline in subjective sleep efficiency (sSE) [Time frame: baseline, Day 14 under the treatment of dimdazenil]
• Change from baseline in Insomnia Severity Index (ISI) total score [Time frame: baseline, Day 14 under the treatment of dimdazenil]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07714772 · LK2026076

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗