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

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 hydroxychloroquine safe for humans?

There is no specific safety data on hydroxychloroquine for Parkinson's disease in the provided research articles, but hydroxychloroquine has been used for other conditions and is generally considered safe for humans when used appropriately, though it can have side effects like any medication. ^{1 2 3 4 5}

How does the drug Hydroxychloroquine differ from other treatments for Parkinson's disease?

Hydroxychloroquine is unique in Parkinson's disease treatment as it is primarily known for its use in autoimmune conditions like lupus and rheumatoid arthritis, and its potential role in PD is still under investigation. Unlike traditional Parkinson's treatments that focus on dopamine replacement, Hydroxychloroquine may offer a novel approach by targeting different pathways, but its effectiveness and mechanism in PD are not yet well-established. ^{4 6 7 8 9}

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. France pubmed.ncbi.nlm.nih.gov

Drugs with potential cardiac adverse effects: Retrospective study in a large cohort of parkinsonian patients. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Antiparkinsonian Agents : Clinically Significant Drug Interactions and Adverse Effects, and Their Management. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Shared Molecular Targets in Parkinson's Disease and Arterial Hypertension: A Systematic Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Adverse effects in the treatment of Parkinson's disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

International guide to drugs for Parkinson's disease. [2013]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Non-Dopaminergic Treatments for Motor Control in Parkinson's Disease: An Update. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Co-morbidity and polypharmacy in Parkinson's disease: insights from a large Scottish primary care database. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Low serum uric acid levels and levodopa-induced dyskinesia in Parkinson's disease. [2023]