Phase 2 Parkinson's Disease Trial, Recruiting NCT06798844 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT06798844
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • People who have been diagnosed with idiopathic Parkinson's disease (Parkinson's that does not have a known cause) according to standard medical diagnostic guidelines
  • People whose Parkinson's symptoms — specifically freezing of gait (sudden episodes where the feet feel stuck to the ground) — are already being managed as well as possible with medication and/or a brain stimulation device (DBS), with no changes to that treatment expected for at least the next 8 weeks
  • People who report experiencing freezing of gait at least once per day, based on a standard questionnaire
  • People who show freezing of gait during a clinical assessment at the hospital, while on their Parkinson's medication
  • People who are able to walk 10 metres on their own without a walking frame (using a cane is allowed)
  • People who are able to understand what the study involves and give their informed consent to take part
  • People between the ages of 40 and 79 (inclusive)

Who may not be able to join:

  • People who have another serious neurological, psychiatric, or other medical condition that could affect the study's results
  • People for whom spinal cord stimulation (SCS) surgery would not be medically safe — for example, due to scar tissue around the spine, an inability to safely stop blood-thinning medications, allergies to implanted devices, or other medical reasons that make surgery too risky
  • People with significant cognitive (thinking and memory) difficulties, as measured by a standard test scoring below 19 out of 30
  • People who have had severe back or leg pain lasting more than 6 months, or a condition called Failed Back Surgery Syndrome, as pain relief from the device could make it harder to measure its effect on freezing of gait
  • People who use a Duodopa pump or apomorphine injections for their Parkinson's treatment
  • People who fall more than once per day on average (this refers to actual falls only, not near-falls)
  • People who do not show any freezing of gait during a pre-surgery assessment conducted at home (confirm with trial site)
  • People who are pregnant, breastfeeding, or who are actively planning a pregnancy

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 14 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Philippe De Vloo, MD, PhD, Prof., Department of Neurosurgery, University Hospitals Leuven

Phone: +32 16 344290

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
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 February 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

FOG-provoking protocol

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: 14 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