Hydroxychloroquine for Parkinson's Disease

Overseen By Shawna Reddie

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Antipsychotics, Antimalarials, Amiodarone, others

Disqualifiers: Atypical parkinsonism, Major surgery, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests hydroxychloroquine to determine if it can safely slow the symptoms of Parkinson's Disease (PD), a condition that affects movement and often worsens over time. Researchers believe that reducing brain inflammation might help, and hydroxychloroquine, an anti-inflammatory drug, could achieve this. Individuals diagnosed with PD in the last four years, with stable symptoms under current treatment, might be suitable participants. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you have been on stable doses of your Parkinson's Disease medications for at least 30 days and that you do not need to change them for 48 weeks. However, you must not have used certain medications like antipsychotics, metoclopramide, or antimalarial drugs within 60 days before starting the trial.

Is there any evidence suggesting that hydroxychloroquine is likely to be safe for humans?

Research shows that people who have taken hydroxychloroquine for other health issues may have a lower risk of developing Parkinson's disease (PD). Although specific safety data for using hydroxychloroquine to treat PD is not yet available, it has been used safely for other conditions. For example, it is generally well-tolerated when used for malaria and rheumatoid arthritis. Common side effects include nausea and stomach pain, but serious reactions are rare. As this study is in its early stages, researchers are closely monitoring safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike standard Parkinson's treatments that primarily aim to replenish dopamine or mimic its effects, Hydroxychloroquine targets inflammation, which is believed to contribute to the progression of the disease. Researchers are excited about this new approach because Hydroxychloroquine, traditionally used for autoimmune conditions, might slow down or modify the disease progression itself rather than just alleviating symptoms. By addressing a different aspect of Parkinson's, this treatment could potentially offer a new avenue for managing the disease more effectively.

What evidence suggests that hydroxychloroquine might be an effective treatment for Parkinson's Disease?

Research suggests that hydroxychloroquine might help slow symptoms of Parkinson’s disease (PD). People using hydroxychloroquine for other health issues appear less likely to develop PD. In animal studies, hydroxychloroquine improved movement and reduced muscle stiffness, common PD symptoms. The drug likely works by reducing inflammation related to abnormal proteins in the brain. While these findings are promising, this trial will specifically evaluate hydroxychloroquine's effectiveness in people with early-treated PD. More research is needed to confirm its effectiveness in this population. ^{1 2 5 6 7}

Who Is on the Research Team?

David Grimes, MD, FRCPC

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease, potentially including those with dementia. Participants should not have taken hydroxychloroquine before and must be in a condition where they can safely receive the drug. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Subject has a score ≥24 on the MoCA scale

I am between 35 and 80 years old.

I have been diagnosed with Parkinson's disease for 6 months to 4 years.

Exclusion Criteria

Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance

Subject has a recent history (last 6 months) of abuse of addictive substances (alcohol, illegal substances), currently uses >21 units of alcohol per week, or is a regular recreational user of sedatives, hypnotics, tranquillizers, or any other addictive agent in the opinion of the investigator

Subject is currently pregnant, is planning pregnancy within the timeframe of the study, or is breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive 200mg of Hydroxychloroquine, orally, twice daily for 48 weeks

48 weeks

Evaluations at baseline, 24 weeks, and 48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hydroxychloroquine

Trial Overview The study tests if hydroxychloroquine (HCQ) is safe for Parkinson's patients and if it can slow symptom progression by targeting inflammation linked to alpha-synuclein protein abnormalities in the brain.

How Is the Trial Designed?

Group I: Hydroxychloroquine Treatment for Early Parkinson's Disease (HCQ-PD) Experimental Treatment 1 Intervention

This is an open-label study where 40 participants with early-treated Parkinson's Disease will be receive 200mg of Hydroxychloroquine, orally, twice daily for 48 weeks.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

Parkinson's disease treatments can effectively manage motor symptoms but are often associated with significant adverse effects, such as nausea, dyskinesias, and psychosis, which can negatively impact patients' quality of life.

The article also highlights potential links between Parkinson's disease treatments and conditions like melanoma and weight loss, indicating the need for careful monitoring of patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events from the treatment of Parkinson's disease. Chou, KL.[2008]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06816810

NCT06816810 | A Study to Evaluate Efficacy, Safety and ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06816810?cond=%22Parkinson's%20Disease%22&intr=%22Antiprotozoal%20Agents%22&viewType=Table&rank=2

A Study to Evaluate Efficacy, Safety and Tolerability of ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35522252/

Hydroxychloroquine attenuated motor impairment and ... Results: The behavioral tests demonstrated that induction of PD increased the muscle rigidity and the number of rotations, which were reversed by HCQ treatment.

4. scienceofparkinsons.com scienceofparkinsons.com/2022/07/16/hcq/

Hydroxychloroquine… I kid you not When they analysed their large dataset, they found an association between hydroxychloroquine and a lower risk of developing Parkinson's. In ...

5. withpower.com withpower.com/trial/phase-2-parkinson-disease-2-2025-3e201

Hydroxychloroquine for Parkinson's Disease 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8967329/

Disease-Modifying Antirheumatic Drugs and Risk of Parkinson ... However, the use of chloroquine/hydroxychloroquine was associated with lower risk of PD, even when the analyses were restricted to exposure that had occurred at ...

7. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06816810/

Trial | NCT06816810 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 ...