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

NCT07714772 | Not Yet Recruiting

• 1 other identifier: LK2026076
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Insomnia; Parkinson's Disease (PD)

Keywords

Insomnia; Parkinson's disease; Daytime Function; effective; safety; dimdazenil

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Night 14

Secondary Outcomes (30)

• 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 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

Study Arms (1)

Parkinson's disease patients with insomnia, aged ≥18 years, male or female

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease with insomnia，aged ≥18 years, male or female

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead
• The Fourth Affiliated Hospital of Soochow University: collaborator
• Changshu Hospital of Traditional Chinese Medicine: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parkinson Disease

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Xy Cheng

CONTACT

0086 0512-67784179; chengxiaoyu2007@126.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share