Phase 2 Parkinson's Disease Trial, Not Yet Recruiting NCT06817200 Sponsor: University Hospital, Toulouse Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Not Yet Recruiting

NCT06817200
Not Yet Recruiting Phase 2

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 for at least 3 years, following recognised diagnostic guidelines, and whose condition is at a moderate stage when their medication is working.
  • People between 30 and 80 years of age.
  • People who have experienced motor fluctuations (periods where their medication wears off and movement becomes difficult) for at least 4 weeks before screening, with an average of at least 2 hours per day in the "off" state (including difficulty moving in the morning), even after their anti-Parkinson's medications have been adjusted to the best possible level.
  • People who have never taken amantadine before (other add-on oral medications for motor fluctuations are allowed).
  • People whose anti-Parkinson's medications have been at a stable dose for at least 4 weeks before screening.
  • People who are covered by a social security or health insurance scheme.
  • People who have signed a written consent form agreeing to take part in the trial.
  • People who are able to complete daily diary forms to track their symptoms.

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 experience severe or unpredictable "off" periods.
  • People with significant or unstable heart or cardiovascular disease, serious psychiatric conditions (such as major depression, dementia, impulse control disorders, or thoughts of suicide), or any other serious medical condition that could put them at increased risk.
  • People with a behavioural disorder rated at a certain level of severity on a specific clinical scale (confirm with trial site).
  • People who have previously been treated with advanced Parkinson's therapies, including continuous apomorphine infusion under the skin, deep brain stimulation, or levodopa-carbidopa intestinal gel.
  • People with significant cognitive impairment, as measured by a standard memory and thinking test scoring below 26 out of 30.
  • People diagnosed with an atypical form of parkinsonism, such as Progressive Supranuclear Palsy, Multiple System Atrophy, Lewy Body Dementia, or Cortico-basal Degeneration.
  • People for whom amantadine is not medically suitable, including those with a known allergy to amantadine or related substances, those taking certain anti-nausea medications, or those with a history of epilepsy, confusion, hallucinations, severe uncontrolled psychiatric conditions, heart failure, fluid retention (peripheral oedema), or skin eczema.
  • People with a history of a serious drug reaction called neuroleptic malignant syndrome, or a condition causing severe muscle breakdown (non-injury-related rhabdomyolysis).
  • People with kidney failure or reduced kidney function (above a certain level on a blood test).
  • People currently experiencing agitation, confusion, delirium, or drug-induced psychosis, or who have a history of these conditions.
  • People who have taken another experimental drug within 30 days or 5 half-lives (whichever is longer) before screening, or who plan to take another experimental drug during the study.
  • People who are pregnant, or people who could become pregnant and are not using highly effective contraception.

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 9 July 2026

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: 0561776039

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

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

the change in motor fluctuation (Off-time)

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: 9 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