Parkinson's Disease Trial, Not Yet Recruiting NCT07714772 Sponsor: Second Affiliated Hospital of Soochow University Condition: Parkinson's Disease
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Parkinson's Disease Trial, Not Yet Recruiting

NCT07714772
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who are willing and able to give written consent to participate after fully understanding the study.
  • People aged 18 or older, of any gender.
  • People who have been diagnosed with Parkinson's disease according to the 2016 Chinese Diagnostic Criteria for Parkinson's Disease, and whose disease stage is rated at 3 or below on a standard scale (modified Hoehn-Yahr).
  • People who experience sleep problems at least three nights per week — such as total sleep time under 6.5 hours, taking more than 30 minutes to fall asleep, waking up two or more times during the night, waking very early in the morning, or having poor sleep quality — along with difficulties during the day as a result, despite having enough time and opportunity to sleep, and where another sleep condition does not fully explain the problem; and whose Parkinson's movement symptoms are well controlled (as measured by a standard assessment score of 30 or below while on medication).
  • People who have been on a stable Parkinson's medication routine for at least 4 weeks before joining, with no changes to the type, dose, or timing of those medications, and no unpredictable changes in movement control or involuntary movements.
  • People for whom their treating doctor has decided to start didazinin as part of their regular care.
  • People who are able to undergo an overnight sleep study (polysomnography).
  • People who are alert, able to communicate normally, and able to fill in a sleep diary on their own.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have a form of parkinsonism that is not standard Parkinson's disease, such as Parkinson-plus syndromes or parkinsonism caused by another condition.
  • People who have used certain sleep medications called benzodiazepine sedative-hypnotics within the 7 days before joining.
  • People who have other serious health conditions, such as cancer, or significant problems with heart, liver, or kidney function.
  • People who have severe obstructive sleep apnea, chronic obstructive pulmonary disease (COPD), breathing difficulties, or a condition called myasthenia gravis.
  • People who are known to be allergic to any ingredient in didazinin.
  • People with moderate to severe depression or anxiety, as measured by standard rating scales (a Hamilton Depression score of 25 or higher, or a Hamilton Anxiety score of 29 or higher).
  • People with a history of substance misuse, such as drug addiction or alcohol dependence.
  • People with a history of epilepsy, schizophrenia, bipolar disorder, developmental delay, or cognitive impairment.
  • People who are pregnant or breastfeeding.
  • People who are unwilling or unable to attend all scheduled follow-up appointments.
  • People who have any other condition that the trial investigator considers would make participation unsuitable — for example, if follow-up within 14 days is not expected to be possible, or if the person is taking other medications that could significantly affect sleep assessment and cannot be safely stopped (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 0086 0512-67784179

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Second Affiliated Hospital of Soochow University
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
10 December 2026

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov