Parkinson's Disease Trial, Not Yet Recruiting NCT06754553 Sponsor: University Hospital, Strasbourg, France Condition: Parkinson's Disease
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Parkinson's Disease Trial, Not Yet Recruiting

NCT06754553
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 have been diagnosed with Parkinson's disease (according to a standard set of medical criteria called the UKPDSBB criteria) for at least 1 year before joining the trial.
  • People aged between 35 and 75 years old, male or female.
  • People who have a moderately severe level of impulse control disorder (ICD), measured by a specific questionnaire called the QUIP-RS, with scores falling within defined ranges — specifically, a combined total score of 10 or more across four problem areas (gambling, buying, hypersexuality, and eating), or at least one area scoring within a particular moderate range (confirm with trial site for exact score thresholds; very high scores above 12 in any area will be reviewed by an independent expert committee).
  • People whose impulse control problems started after their Parkinson's disease diagnosis and after they began taking dopaminergic medications.
  • People who have been taking dopaminergic medications for at least 3 months before joining the trial.
  • People who have been on a stable dose of their Parkinson's and related medications (such as levodopa, dopamine agonists, and certain other drugs) for at least 1 month before joining, and who are willing to stay on those same doses throughout the trial.
  • People who have health insurance.
  • People (or their legal guardian or curator) who have signed the written consent form for the PIMPARK study.
  • Women who could become pregnant must have been using an effective form of contraception for at least 1 month before joining, and must continue using it until 8 weeks after the last dose of the study drug.
  • People who took part in the PIMPARK study (reference study PHRC N 2015 – HUS N°6398) during the period from 23 October 2020 to 17 June 2024.
  • People who, after being informed, do not object to their data from the PIMPARK study being reused for the purposes of this research.

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 been diagnosed with a different type of movement disorder, such as multiple system atrophy, progressive supranuclear palsy, Lewy body dementia, or corticobasal degeneration.
  • People who have a known allergy or sensitivity to the study drug or medications in the same drug family.
  • People who have had a stroke, heart attack, heart failure, or other serious uncontrolled medical illness or heart function problem within the 6 months before joining.
  • People with a personal history of a heart condition called long QT syndrome.
  • People whose heart electrical activity test (ECG) at the screening visit shows a prolonged QT interval (above 450 ms).
  • People who have taken antipsychotic medications in the 3 months before joining the trial.
  • People who are taking certain medications known to cause a specific dangerous heart rhythm problem (called torsade de pointes), unless those medications have been stopped for long enough before joining (confirm with trial site for details).
  • People who have abnormal blood electrolyte levels (such as low potassium or low calcium) that have not been corrected, measured at or within 8 days before joining — specific acceptable ranges apply (confirm with trial site).
  • People who are taking certain medications that strongly affect how the body processes the study drug (specific drugs include carbamazepine, rifampicin, phenytoin, modafinil, efavirenz, azole antifungals, protease inhibitors, and macrolide antibiotics), unless those medications have been stopped for long enough before joining.
  • People who are taking certain herbal or medicinal plant products that interact with the body's drug-processing system (including Echinacea, Piperina, Artemisia, St. John's Wort, and Ginkgo), unless stopped for long enough before joining.
  • People whose score on a standard memory and thinking test (called the MoCA) is below 20 at the screening visit, which may indicate dementia.
  • People who are experiencing severe depression or significant thoughts of suicide (based on a specific score on a standard assessment scale) at the screening visit.
  • People who have had deep brain stimulation (DBS) surgery within the past year before joining, or whose DBS settings were changed less than one month before joining.
  • People who have been diagnosed with a blood cancer or solid tumour cancer within the 5 years before joining.
  • People with severely reduced kidney function (as measured by a specific calculation, with a result below 30 mL/min) at or within 8 days before joining.
  • People with a clinically significant liver condition.
  • People who are currently taking part in another clinical trial involving a drug or medical device.
  • People who have language difficulties that would prevent them from understanding or participating properly, or who the investigator considers should not participate for other reasons.
  • People who have received an experimental treatment within 30 days before joining.
  • Women who are pregnant, breastfeeding, of childbearing potential without effective contraception, or who plan to become pregnant.

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 27 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.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

Contact this trial

Phone: +33 3 88 12 85 35

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
Registry
ClinicalTrials.gov
Start date
1 February 2025
Est. completion
1 February 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Change in ICD (Impulsive Control Disorders) severity after 8 weeks of treatment evaluated by QUestionnaire for Impulse-compulsive disorder in Parkinson's disease Rating Scale (QUIP-RS).

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: 27 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