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NCT04935762

NCT04935762
Withdrawn Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are between 30 and 80 years old (inclusive) at the time you give your consent to take part.
  • You have been diagnosed with Parkinson's Disease using a specific standard set of diagnostic guidelines (confirm with trial site).
  • You have been experiencing "freezing of gait" — sudden episodes where your feet feel stuck and you cannot move them even though you intend to walk — for at least 3 months, including at least one of these patterns: difficulty starting to walk, freezing when turning or going through doorways, unexpected freezing while already walking, or freezing when doing something else at the same time.
  • You freeze at least once a week, with episodes lasting at least 2 seconds.
  • You are willing to attend some visits having stopped certain Parkinson's medications beforehand for a set period of time, as instructed by the study team.
  • If you are a man who has not had a vasectomy or a medical reason for infertility, you must agree to use a condom during the study when having sex with a woman who could become pregnant; if your partner is pregnant or breastfeeding, you must agree to use a condom or avoid intercourse until after your follow-up visit.
  • If you are a woman who could become pregnant and have a male partner, you must have a negative pregnancy test and agree to use reliable contraception, be in a relationship with a confirmed sterile partner, or abstain from intercourse for the duration of the study and for 30 days after the last dose.
  • If you are a woman who cannot become pregnant (e.g., post-menopausal), you may still be eligible if this is documented.
  • Your body weight is at least 50 kg and your Body Mass Index (BMI — a measure of weight relative to height) is between 18 and 35 at the time of screening.
  • Any other health conditions you have (for example, high blood pressure or high cholesterol) have been stable and managed for at least 3 months before the screening visit.
  • You are willing and able to follow the study rules and procedures, including filling in questionnaires and wearing sensor devices; if you cannot give consent yourself, a legally authorised representative may do so on your behalf.

Who may not be able to join:

  • You have high blood pressure that is not well controlled even with lifestyle changes or medication.
  • You show signs of other brain or movement disorders similar to but different from Parkinson's Disease (confirm with trial site).
  • You have a current or recent history (within the past 2 years) of epilepsy, a brain lesion, a head injury involving loss of consciousness, or a diagnosed serious mental health condition such as schizophrenia or bipolar disorder, or you have unstable psychiatric symptoms.
  • You have a significant medical condition or abnormal test result that the study team believes makes it unsafe for you to take an experimental drug (confirm with trial site).
  • You have a history of cancer, with the exception of certain fully treated and cured skin cancers.
  • You have any significant illness identified through your medical history, a physical examination, a heart tracing (ECG), or blood/lab tests at the screening visit.
  • Your heart tracing (ECG) shows abnormal results, including a specific measurement called QTcF that is too high (over 450 ms for men or 470 ms for women), a heart rate below 50 beats per minute, or significant abnormalities in how electrical signals travel through your heart.
  • Your kidneys are not working well enough, based on a specific calculation of kidney function (confirm with trial site).
  • You are currently taking any prescription medicines, over-the-counter medicines, or herbal supplements that are not allowed by the study.
  • You have taken part in another drug trial within the past 90 days (or longer, depending on the drug), or you are currently enrolled in another treatment study.
  • You have had a known or suspected problem with alcohol or substance misuse in the past 12 months.
  • You have had thoughts of suicide with intent or a plan within the 3 months before the screening visit.
  • You currently have an active COVID-19 infection.
  • You have a reason you cannot wear the study's body sensor patches, such as having an implanted pacemaker or defibrillator, another active implanted device, or a known allergy to the sensors.
  • You have a known allergy to adhesives or hydrogel (

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

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Withdrawn
Phase
Phase 2
Sponsor
CuraSen Therapeutics, Inc.
Registry
clinicaltrials_gov
Start date
1 June 2024
Est. completion
1 December 2024

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from Baseline in Gait as Captured by Video Recordings

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov