A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
NCT ID: NCT06816810
Last Updated: 2025-02-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
40 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-03-31
Study Completion Date
2027-03-31
Brief Summary
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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.
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Detailed Description
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Parkinson disease (PD) is a progressive neurodegenerative disorder pathologically characterized by the loss of dopaminergic neurons in the substantia nigra and the presence of α-synuclein protein inclusions termed Lewy bodies. There is increasing evidence of the important role of inflammation in the pathophysiology in PD. Studies of the innate and adaptive immune systems provide evidence that immune dysregulation in both the periphery and brain can cause upregulation of inflammatory cytokines that initiate a cascade of pro-inflammatory signaling events that ultimately result in the neurotoxicity. Post-mortem studies reveal activated microglia and T-cells and immunoglobulin deposition in brain tissue from PD subjects. Alterations in immune cells are detected in living PD subjects, with most consistent findings pointing to T-cell and monocyte changes. Peptides derived from αsynuclein, the key protein that aggregates in PD and the primary component of Lewy bodies, can activate T-cells from PD patients. Pro-inflammatory cytokines and chemokines are elevated in blood and cerebrospinal fluid (CSF) specimens from PD subjects. In vivo evaluation of microglial activity has been performed using positron emission tomography (PET) ligands to measure and shown evidence of neuroinflammation in the brains of patients with PD. Mutations in more than 20 genes have been identified that cause PD with many of them (e.g. LRRK2, SNCA, GBA, PRKN, PINK1) encoding proteins that modulate immune function. Animal PD models show inflammatory changes, and manipulation of inflammation can alter neurodegeneration in animal models. A wide range of epidemiologic studies have supported the role of inflammation in PD that includes data to suggest that ibuprofen and treatment of inflammatory bowel disease with anti- tumor necrosis factor (TNF) biologics are associated with reduced PD risk.
The repurposing of generic drugs is a strategy to identify new treatment options for PD because of their known safety profile. Hydroxychloroquine (HCQ) was approved for medical use for over 50 years as a treatment for malaria, systemic lupus erythematosus, and rheumatoid arthritis and is on the World Health Organization's List of Essential Medicines. It belongs to a class of medications known as disease-modifying antirheumatic drug that can reduce skin problems in lupus and prevent swelling/pain in arthritis. It has been shown to interfere with lysosomal activity and autophagy, interact with membrane stability and alter signaling pathways and transcriptional activity, which can result in inhibition of cytokine production and modulation of certain co-stimulatory molecules. HCQ has been studied in multiple sclerosis (MS) which is an inflammatory and neurodegenerative disease of the central nervous. In mice models of MS, HCQ has been shown to inhibit microglia activation and attenuate the severity of disease. Hydroxychloroquine reduces microglial activity and attenuates experimental autoimmune encephalomyelitis. A phase II futility trial of 200 mg bid HCQ in 35 patients with primary progressive MS was associated with reduced disability worsening over 18 months. HCQ was well tolerated overall, with adverse events in 82% and serious adverse events in 12% of participants. All serious adverse events were felt to be unlikely related to HCQ. In this study, HCQ treatment attenuated the increase of neurofilament-light (NfL) after 6 months of treatment and up to 18 months of follow-up, suggesting a treatment effect of HCQ over these biomarkers
The repurposing of generic drugs is a strategy to identify new treatment options for PD because of their known safety profile. Hydroxychloroquine (HCQ) was approved for medical use for over 50 years as a treatment for malaria, systemic lupus erythematosus, and rheumatoid arthritis and is on the World Health Organization's List of Essential Medicines. It belongs to a class of medications known as disease-modifying antirheumatic drug that can reduce skin problems in lupus and prevent swelling/pain in arthritis. It has been shown to interfere with lysosomal activity and autophagy, interact with membrane stability and alter signaling pathways and transcriptional activity, which can result in inhibition of cytokine production and modulation of certain co-stimulatory molecules. HCQ has been studied in multiple sclerosis (MS) which is an inflammatory and neurodegenerative disease of the central nervous. In mice models of MS, HCQ has been shown to inhibit microglia activation and attenuate the severity of disease. Hydroxychloroquine reduces microglial activity and attenuates experimental autoimmune encephalomyelitis. A phase II futility trial of 200 mg bid HCQ in 35 patients with primary progressive MS was associated with reduced disability worsening over 18 months. HCQ was well tolerated overall, with adverse events in 82% and serious adverse events in 12% of participants. All serious adverse events were felt to be unlikely related to HCQ. In this study, HCQ treatment attenuated the increase of neurofilament-light (NfL) after 6 months of treatment and up to 18 months of follow-up, suggesting a treatment effect of HCQ over these biomarkers
Conditions
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Parkinson&Amp;#39;s Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Hydroxychloroquine Treatment for Early Parkinson's Disease (HCQ-PD)
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.
Group Type
EXPERIMENTAL
Hydroxychloroquine (HCQ)
Intervention Type
DRUG
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.
Interventions
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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.
Intervention Type
DRUG
Eligibility Criteria
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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, compliance with the requirements and restrictions that are listed in the informed consent form (ICF) and this protocol, and authorization to use confidential health information in accordance with national and local subject privacy regulations
* 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, compliance with the requirements and restrictions that are listed in the informed consent form (ICF) and this protocol, and authorization to use confidential health information in accordance with national and local subject privacy regulations
Exclusion Criteria
* The subject has atypical or secondary parkinsonism by medical history or in the opinion of the investigator. Atypical parkinsonism includes, but is not limited to, diagnoses of progressive supranuclear palsy, cortico-basal syndrome, and multiple system atrophy. Secondary parkinsonism includes drug-induced, toxin-induced, postinfectious, posttraumatic, or vascular parkinsonism.
* The subject has a history of (within 60 days before initiation of screening) or has planned upcoming major surgery that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would pose an unacceptable risk to the subject in the opinion of the investigator.
* The subject has any active or chronic disease including but not limited to cardiomyopathy or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study or pose an unacceptable risk to the subject in the opinion of the investigator based on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests.
* Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance.
* The 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.
* The subject is currently pregnant, is planning pregnancy within the timeframe of the study, or is breastfeeding.
* Patient has a history of psoriasis or porphyria.
* The subject has used any of the following medications within 60 days before Baseline: typical or atypical antipsychotics (including, but not limited to, clozapine, pimavanserin, olanzapine, risperidone, and aripiprazole), metoclopramide, prochlorperazine, methyldopa, tetrabenazine, azithromycin, antimalarial drugs, tamoxifen, amiodarone, dapsone, or digoxin.
* The subject has received a vaccination within 14 days before administration of the first dose of IMP.
* The subject has a prior history of or there is a plan to undergo Deep Brain stimulation, brain lesional procedures (i.e., thalamotomy), or focused ultrasound; to initiate gene therapy treatment for PD; or to initiate use of any formulation of intestinal infusion or continuous subcutaneous infusion of PD medications during the following 48 weeks.
* The subject is currently participating in or has participated in an investigational drug study within 3 months or 5 half-lives, whichever is longer; in a therapeutic device study within 3 months before the first dose of IMP; or has previously participated in a gene therapy trial. Concurrent participation in an observational study is acceptable.
* The subject has renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) of \<60 mL/min at screening.
* The subject has cirrhosis or any of the following laboratory values at screening: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 times the upper limit of normal (ULN) or bilirubin \>2 × ULN except if the subject has known or suspected Gilbert's disease.
* The subject has a QTcF (QT interval corrected for heart rate by Fridericia's method) value \>450 msec if male or \>470 msec if female at screening.
* The subject has previously received hydroxychloroquine or has a known allergy or hypersensitivity to hydroxychloroquine or any components of the formulation.
* The subject has a history of bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
* The subject has a history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
* The subject is unable or unlikely to comply with the dosing schedule or study evaluations in the judgment of the investigator.
* The subject is a member of a protected/vulnerable population, defined as persons who are pregnant, parturient, or breastfeeding; persons who are deprived of liberty; persons who are admitted to a health or social institution for purposes other than research; adults who are under legal protection or who are unable to express their consent; persons who are in an emergency situation and are unable to express their prior consent; and persons are who are non-affiliated or a non-beneficiary of a social security system.
* The subject is a relative of the investigator or sponsor or the relative of an employee of the sponsor.
* The subject has a history of retinopathy or is found to have a significant retina finding on screening ophthalmologic examination.
* The subject has a history of (within 60 days before initiation of screening) or has planned upcoming major surgery that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would pose an unacceptable risk to the subject in the opinion of the investigator.
* The subject has any active or chronic disease including but not limited to cardiomyopathy or condition other than PD that could interfere with, or for which the treatment might interfere with, the conduct of the study or pose an unacceptable risk to the subject in the opinion of the investigator based on medical history, physical examination, vital signs, 12-lead ECG, or clinical laboratory tests.
* Minor deviations of laboratory values from the normal range may be acceptable if judged by the investigator to have no/minor clinical relevance.
* The 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.
* The subject is currently pregnant, is planning pregnancy within the timeframe of the study, or is breastfeeding.
* Patient has a history of psoriasis or porphyria.
* The subject has used any of the following medications within 60 days before Baseline: typical or atypical antipsychotics (including, but not limited to, clozapine, pimavanserin, olanzapine, risperidone, and aripiprazole), metoclopramide, prochlorperazine, methyldopa, tetrabenazine, azithromycin, antimalarial drugs, tamoxifen, amiodarone, dapsone, or digoxin.
* The subject has received a vaccination within 14 days before administration of the first dose of IMP.
* The subject has a prior history of or there is a plan to undergo Deep Brain stimulation, brain lesional procedures (i.e., thalamotomy), or focused ultrasound; to initiate gene therapy treatment for PD; or to initiate use of any formulation of intestinal infusion or continuous subcutaneous infusion of PD medications during the following 48 weeks.
* The subject is currently participating in or has participated in an investigational drug study within 3 months or 5 half-lives, whichever is longer; in a therapeutic device study within 3 months before the first dose of IMP; or has previously participated in a gene therapy trial. Concurrent participation in an observational study is acceptable.
* The subject has renal insufficiency as defined by an estimated glomerular filtration rate (eGFR) of \<60 mL/min at screening.
* The subject has cirrhosis or any of the following laboratory values at screening: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 times the upper limit of normal (ULN) or bilirubin \>2 × ULN except if the subject has known or suspected Gilbert's disease.
* The subject has a QTcF (QT interval corrected for heart rate by Fridericia's method) value \>450 msec if male or \>470 msec if female at screening.
* The subject has previously received hydroxychloroquine or has a known allergy or hypersensitivity to hydroxychloroquine or any components of the formulation.
* The subject has a history of bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia
* The subject has a history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
* The subject is unable or unlikely to comply with the dosing schedule or study evaluations in the judgment of the investigator.
* The subject is a member of a protected/vulnerable population, defined as persons who are pregnant, parturient, or breastfeeding; persons who are deprived of liberty; persons who are admitted to a health or social institution for purposes other than research; adults who are under legal protection or who are unable to express their consent; persons who are in an emergency situation and are unable to express their prior consent; and persons are who are non-affiliated or a non-beneficiary of a social security system.
* The subject is a relative of the investigator or sponsor or the relative of an employee of the sponsor.
* The subject has a history of retinopathy or is found to have a significant retina finding on screening ophthalmologic examination.
Minimum Eligible Age
35 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David Grimes, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Site Status
Countries
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Canada
Central Contacts
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Facility Contacts
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References
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Galna B, Lord S, Burn DJ, Rochester L. Progression of gait dysfunction in incident Parkinson's disease: impact of medication and phenotype. Mov Disord. 2015 Mar;30(3):359-67. doi: 10.1002/mds.26110. Epub 2014 Dec 27.
Reference Type
BACKGROUND
Gisondi P, Piaserico S, Bordin C, Bellinato F, Tozzi F, Alaibac M, Girolomoni G, Naldi L. The safety profile of hydroxychloroquine: major cutaneous and extracutaneous adverse events. Clin Exp Rheumatol. 2021 Sep-Oct;39(5):1099-1107. doi: 10.55563/clinexprheumatol/styx9u. Epub 2021 Feb 15.
Reference Type
BACKGROUND
Harms AS, Ferreira SA, Romero-Ramos M. Periphery and brain, innate and adaptive immunity in Parkinson's disease. Acta Neuropathol. 2021 Apr;141(4):527-545. doi: 10.1007/s00401-021-02268-5. Epub 2021 Feb 8.
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BACKGROUND
Hedya SA, Safar MM, Bahgat AK. Hydroxychloroquine antiparkinsonian potential: Nurr1 modulation versus autophagy inhibition. Behav Brain Res. 2019 Jun 3;365:82-88. doi: 10.1016/j.bbr.2019.02.033. Epub 2019 Feb 22.
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Holden SK, Finseth T, Sillau SH, Berman BD. Progression of MDS-UPDRS Scores Over Five Years in De Novo Parkinson Disease from the Parkinson's Progression Markers Initiative Cohort. Mov Disord Clin Pract. 2018 Jan-Feb;5(1):47-53. doi: 10.1002/mdc3.12553. Epub 2017 Sep 22.
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Hooks M, Bart B, Vardeny O, Westanmo A, Adabag S. Effects of hydroxychloroquine treatment on QT interval. Heart Rhythm. 2020 Nov;17(11):1930-1935. doi: 10.1016/j.hrthm.2020.06.029. Epub 2020 Jun 28.
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Imanova Yaghji N, Kan EK, Akcan S, Colak R, Atmaca A. Hydroxychloroquine Sulfate Related Hypoglycemia In A Non-Diabetic COVID-19 Patient: A Case Report and Literature Review. Postgrad Med. 2021 Jun;133(5):548-551. doi: 10.1080/00325481.2021.1889820. Epub 2021 Feb 26.
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BACKGROUND
Jarzyna R, Kiersztan A, Lisowa O, Bryla J. The inhibition of gluconeogenesis by chloroquine contributes to its hypoglycaemic action. Eur J Pharmacol. 2001 Oct 12;428(3):381-8. doi: 10.1016/s0014-2999(01)01221-3.
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Kwak YT, Yang Y, Park SY. Chloroquine-associated psychosis mimicking very late-onset schizophrenia: Case Report. Geriatr Gerontol Int. 2015 Aug;15(8):1096-7. doi: 10.1111/ggi.12490. No abstract available.
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Li D, Hong X, Chen T. Association Between Rheumatoid Arthritis and Risk of Parkinson's Disease: A Meta-Analysis and Systematic Review. Front Neurol. 2022 May 11;13:885179. doi: 10.3389/fneur.2022.885179. eCollection 2022.
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Lipner SR, Wang Y. Retrospective analysis of dermatologic adverse events associated with hydroxychloroquine reported to the US Food and Drug Administration. J Am Acad Dermatol. 2020 Nov;83(5):1527-1529. doi: 10.1016/j.jaad.2020.07.007. Epub 2020 Jul 8. No abstract available.
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Liu SY, Qiao HW, Song TB, Liu XL, Yao YX, Zhao CS, Barret O, Xu SL, Cai YN, Tamagnan GD, Sossi V, Lu J, Chan P. Brain microglia activation and peripheral adaptive immunity in Parkinson's disease: a multimodal PET study. J Neuroinflammation. 2022 Aug 29;19(1):209. doi: 10.1186/s12974-022-02574-z.
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Murray JJ, Lee MS. Re: Marmor et al.: American Academy of Ophthalmology Statement: Recommendations on screening for chloroquine and hydroxychloroquine retinopathy (2016 Revision). (Ophthalmology 2016;123:1386-1394). Ophthalmology. 2017 Mar;124(3):e28-e29. doi: 10.1016/j.ophtha.2016.06.062. No abstract available.
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BACKGROUND
McGhie TK, Harvey P, Su J, Anderson N, Tomlinson G, Touma Z. Electrocardiogram abnormalities related to anti-malarials in systemic lupus erythematosus. Clin Exp Rheumatol. 2018 Jul-Aug;36(4):545-551. Epub 2018 Apr 13.
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Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
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O'Laughlin JP, Mehta PH, Wong BC. Life Threatening Severe QTc Prolongation in Patient with Systemic Lupus Erythematosus due to Hydroxychloroquine. Case Rep Cardiol. 2016;2016:4626279. doi: 10.1155/2016/4626279. Epub 2016 Jul 12.
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Paakinaho A, Koponen M, Tiihonen M, Kauppi M, Hartikainen S, Tolppanen AM. Disease-Modifying Antirheumatic Drugs and Risk of Parkinson Disease: Nested Case-Control Study of People With Rheumatoid Arthritis. Neurology. 2022 Mar 22;98(12):e1273-e1281. doi: 10.1212/WNL.0000000000013303. Epub 2022 Jan 21.
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Peter I, Dubinsky M, Bressman S, Park A, Lu C, Chen N, Wang A. Anti-Tumor Necrosis Factor Therapy and Incidence of Parkinson Disease Among Patients With Inflammatory Bowel Disease. JAMA Neurol. 2018 Aug 1;75(8):939-946. doi: 10.1001/jamaneurol.2018.0605.
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BACKGROUND
Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
Reference Type
BACKGROUND
Qin H, Buckley JA, Li X, Liu Y, Fox TH 3rd, Meares GP, Yu H, Yan Z, Harms AS, Li Y, Standaert DG, Benveniste EN. Inhibition of the JAK/STAT Pathway Protects Against alpha-Synuclein-Induced Neuroinflammation and Dopaminergic Neurodegeneration. J Neurosci. 2016 May 4;36(18):5144-59. doi: 10.1523/JNEUROSCI.4658-15.2016.
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BACKGROUND
Samii A, Etminan M, Wiens MO, Jafari S. NSAID use and the risk of Parkinson's disease: systematic review and meta-analysis of observational studies. Drugs Aging. 2009;26(9):769-79. doi: 10.2165/11316780-000000000-00000.
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Schrezenmeier E, Dorner T. Mechanisms of action of hydroxychloroquine and chloroquine: implications for rheumatology. Nat Rev Rheumatol. 2020 Mar;16(3):155-166. doi: 10.1038/s41584-020-0372-x. Epub 2020 Feb 7.
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BACKGROUND
Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.
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BACKGROUND
Srinivasa A, Tosounidou S, Gordon C. Increased Incidence of Gastrointestinal Side Effects in Patients Taking Hydroxychloroquine: A Brand-related Issue? J Rheumatol. 2017 Mar;44(3):398. doi: 10.3899/jrheum.161063. No abstract available.
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BACKGROUND
Sterling NW, Cusumano JP, Shaham N, Piazza SJ, Liu G, Kong L, Du G, Lewis MM, Huang X. Dopaminergic modulation of arm swing during gait among Parkinson's disease patients. J Parkinsons Dis. 2015;5(1):141-50. doi: 10.3233/JPD-140447.
Reference Type
BACKGROUND
Wilson J, Alcock L, Yarnall AJ, Lord S, Lawson RA, Morris R, Taylor JP, Burn DJ, Rochester L, Galna B. Gait Progression Over 6 Years in Parkinson's Disease: Effects of Age, Medication, and Pathology. Front Aging Neurosci. 2020 Oct 15;12:577435. doi: 10.3389/fnagi.2020.577435. eCollection 2020.
Reference Type
BACKGROUND
Yacoubian TA, Fang YD, Gerstenecker A, Amara A, Stover N, Ruffrage L, Collette C, Kennedy R, Zhang Y, Hong H, Qin H, McConathy J, Benveniste EN, Standaert DG. Brain and Systemic Inflammation in De Novo Parkinson's Disease. Mov Disord. 2023 May;38(5):743-754. doi: 10.1002/mds.29363. Epub 2023 Feb 28.
Reference Type
BACKGROUND
Other Identifiers
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Taller Than PD
Identifier Type: -
Identifier Source: org_study_id
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A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASE
NCT01684475
UNKNOWN
PHASE1/PHASE2
Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
NCT03185481
TERMINATED
PHASE2
The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease
NCT06167681
RECRUITING
PHASE1/PHASE2
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
NCT01096186
COMPLETED
PHASE3
Safety and Effectiveness of Intermittent Hypoxia Treatment in Parkinson's Disease
NCT05948761
COMPLETED
PHASE1/PHASE2
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
NCT07174310
RECRUITING
PHASE3
A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)
NCT00148486
COMPLETED
PHASE2
Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's
NCT05832775
WITHDRAWN
PHASE1
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
NCT03877510
COMPLETED
PHASE3
Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
NCT06614153
COMPLETED
PHASE2
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease
NCT04777331
ACTIVE_NOT_RECRUITING
PHASE2
Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
NCT03971617
TERMINATED
PHASE2/PHASE3
A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
NCT03815071
UNKNOWN
EARLY_PHASE1
Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's Disease
NCT02382198
UNKNOWN
PHASE2
A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants
NCT06088784
COMPLETED
PHASE1
Role of Pentoxifylline and Celecoxib in Parkinsonism
NCT05962957
COMPLETED
PHASE2
Intranasal Glutathione in Parkinson's Disease
NCT01398748
COMPLETED
PHASE1