A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Park… (NCT06816810) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Canada40 participantsStarted 2025-03
Plain-language summary
The purpose of this study is to determine if hydroxychloroquine is safe to take and whether there is potential for it to slow the progression of PD symptoms. This will be done by comparing how PD symptoms progress throughout the study compared to how people with PD typically progress. Within PD, it is thought that an inflammation response is associated with abnormal forms of a protein called alpha-synuclein in the brain. Individuals who have taken this medication for other conditions have been shown to be less likely to develop PD than people who have not taken this medication. Therefore, it is hoped that the study drug may interrupt the inflammation response and in turn stop/delay the progression of PD.
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is ≥35 and ≤80 years of age at the time of informed consent.
* The subject has a clinical diagnosis of PD for at least 6 months and for no longer than 4 years before initiation of screening as confirmed by a neurologist using the MDS Criteria for Parkinson's Disease (Postuma, Berg et al. 2015)
* The subject has a Hoehn and Yahr score ≤2.
* The subject has been on stable doses of PD medications for at least 30 days and the investigator does not anticipate they will require a change of their usual PD medications for a period of 48 weeks.
* The subject has a score ≥24 on the MoCA scale.
* The subject does not have severe motor fluctuations or disabling dyskinesias in the clinical judgment of the investigator (MDS-UPDRS score \> 2 on any item IV).
* If a sexually active man or a woman of childbearing potential, the subject agrees to use highly effective birth control or to remain abstinent during the trial and for 30 days after the last dose of HCQ. Acceptable (highly effective) methods of contraception for this study include hormonal contraceptives or implant); intrauterine device or system; complete abstinence from sexual intercourse if this is the subject's usual and preferred lifestyle; or sexual partner with surgical sterilization (e.g., tubal ligation, hysterectomy and/or bilateral oophorectomy, vasectomy).
* The subject is capable of giving signed informed consent, which includes understanding the purpose and risks of the study, complianc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is using hydroxychloroquine, a drug that's already approved for conditions like lupus and malaria — can you help me understand why researchers think it might slow down the motor progression of Parkinson's disease, and does that rationale make sense for my specific situation?
2Since this is a Phase 2 trial and it hasn't started recruiting yet, what does that mean for how much is already known about whether hydroxychloroquine is safe and effective for Parkinson's patients like me?
3The trial is measuring motor progression using the MDS-UPDRS Part III scale — can you explain what that test involves and how my current score on that scale might compare to the kind of patients they're likely to enroll?
4Hydroxychloroquine is known to have some side effects, including potential effects on the eyes and heart — given my overall health history, are those risks something I should be especially concerned about if I were to consider a trial like this?
5Before a trial like this even opens for recruitment, would it make more sense for me to start one of the established standard treatments for Parkinson's disease, and would doing so affect my ability to potentially join this or a similar study later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: Throughout enrollment (4 weeks of screening) to the end of treatment at 48 weeks and 4-week safety follow-up.
2
Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical Motor Progression Using MDS-UPDRS Part III
Timeframe: Throughout enrollment to the end of treatment at 48 weeks. MDS-UPDRS Part III will be evaluated at baseline, 24 weeks and 48 weeks.