Printed from Voxsanity (voxsanity.com.au) — NCT06816810 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Parkinson's Disease Trial, Not Yet Recruiting
NCT06816810
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 aged between 35 and 80 years old at the time of giving consent to join the study.
- People who have been diagnosed with Parkinson's disease (PD) by a neurologist for at least 6 months but no longer than 4 years before the start of screening.
- People whose Parkinson's disease is at a mild stage, as measured by a standard scale called the Hoehn and Yahr score (score of 2 or below).
- People who have been on a stable dose of their Parkinson's medications for at least 30 days, and whose doctor does not expect their medications to need changing over the next 48 weeks.
- People who score 24 or higher on a standard memory and thinking test called the MoCA scale.
- People who do not have severe movement problems or uncontrolled involuntary movements, as judged by the treating doctor using a standard Parkinson's assessment tool.
- People who are sexually active or capable of becoming pregnant who agree to use highly effective contraception or to remain abstinent during the trial and for 30 days after the last dose of the study drug (acceptable methods include hormonal contraceptives, an intrauterine device or system, complete abstinence if that is their usual lifestyle, or having a partner who has had a surgical sterilisation procedure).
- People who are able to understand the purpose and risks of the study, follow its requirements, and give their signed consent to participate.
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 an atypical or secondary form of parkinsonism — for example, conditions such as progressive supranuclear palsy, cortico-basal syndrome, multiple system atrophy, or parkinsonism caused by drugs, toxins, infections, injury, or problems with blood supply to the brain.
- People who have had major surgery in the 60 days before screening, or who have major surgery planned, that could interfere with the study or pose a risk to them.
- People who have an active or ongoing health condition (other than Parkinson's disease), such as a heart muscle disease, that could interfere with the study or pose an unacceptable risk, as assessed by the doctor based on medical history, physical examination, vital signs, heart tracing (ECG), or blood/lab tests.
- People who have recently (within the last 6 months) misused alcohol or illegal substances, who regularly drink more than 21 units of alcohol per week, or who regularly use sedatives, sleeping pills, tranquillisers, or other habit-forming substances.
- People who are currently pregnant, planning to become pregnant during the study period, or who are breastfeeding.
- People who have a history of the skin condition psoriasis or a condition called porphyria (a disorder affecting how the body processes certain chemicals).
- People who have taken certain medications in the 60 days before the baseline visit, including certain antipsychotics (such as clozapine, olanzapine, risperidone, aripiprazole, or pimavanserin), metoclopramide, prochlorperazine, methyldopa, tetrabenazine, azithromycin, antimalarial drugs, tamoxifen, amiodarone, dapsone, or digoxin.
- People who have received a vaccination within 14 days before taking the first dose of the study drug.
- People who have previously had, or have plans to undergo, deep brain stimulation, a brain lesioning procedure (such as thalamotomy), focused ultrasound, gene therapy for Parkinson's disease, or continuous infusion of Parkinson's medications, within the next 48 weeks.
- People who are currently taking part in, or who have taken part in, another investigational drug study within 3 months or 5 half-lives (whichever is longer), a therapeutic device study within 3 months, or who have previously taken part in a gene therapy trial (participation in an observational study is acceptable).
- People whose kidneys are not functioning well enough, as shown by a kidney function test result below a certain level (eGFR below 60 mL/min) at screening.
- People who have cirrhosis (scarring of the liver) or certain abnormal liver test results at screening, unless they have a known condition called Gilbert's disease.
- People whose heart's electrical activity, as measured by an ECG, shows a particular reading above a certain threshold (QTcF above 450 msec for men or above 470 msec for women) at screening.
- People who have previously taken hydroxychloroquine, or who have a known allergy or sensitivity to hydroxychloroquine or any of its ingredients.
- People who have a history of bone marrow failure, anaemia, aplastic anaemia, agranulocytosis, low white blood cell count (leukopenia), or low platelet count (thrombocytopenia).
- People who have a history of a condition called G-6-PD deficiency (an inherited enzyme deficiency that can affect red blood cells).
- People who, in the doctor's judgement, are unlikely or unable to follow the dosing schedule or attend the study assessments.
- People who belong to a protected or vulnerable group, including those who are pregnant, in labour, or breastfeeding; those who are in custody or detained; those admitted to a health or social care facility for reasons other than research; adults under legal protection or unable to give consent; people in emergency situations who cannot give prior consent; or people who are not affiliated with or covered by a social security system.
- People who are a family member of the investigator or the study sponsor, or a family member of a sponsor employee.
- People who have a history of eye disease affecting the retina, or who are found to have a significant retinal problem during the eye examination at screening.
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.
Contact this trial
Principal Investigator: David Grimes, MD, FRCPC, The Ottawa Hospital
Phone: 613-798-5555
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
Sponsor
Ottawa Hospital Research Institute
Registry
ClinicalTrials.gov
Start date
1 March 2025
Est. completion
1 September 2026
Where this trial is recruiting
🇨🇦 Canada
Primary endpoints
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0; Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical Motor Progression Using MDS-UPDRS Part III
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.