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A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease

NCT06816810 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

  • Parkinson&Amp;#39;s Disease

Interventions

DRUG

Hydroxychloroquine (HCQ)

The intervention involves hydroxychloroquine (HCQ), administered orally in 200 mg tablets, with a dosing schedule of 200 mg twice daily (400 mg per day). The treatment duration is 48 weeks, after which participants will enter a 4-week safety follow-up period. HCQ will be taken alongside stable doses of Parkinson's disease (PD) medications, with no anticipated changes during the study. Monitoring for adverse events, laboratory assessments, and efficacy evaluations will occur regularly throughout the 12-month period. The study does not include a placebo group or other treatment arms.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • David Grimes, MD, FRCPC · The Ottawa Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06816810 on ClinicalTrials.gov