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

Sponsor
Second Affiliated Hospital of Soochow University
Study ID
NCT07714772
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Dec 10, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

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

Primary Outcome Measure

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 ]

Central Contacts

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