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Parkinson&Amp;#39;s DiseasePhase 2NCT06816810

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

A Phase 2 study testing Hydroxychloroquine (HCQ) in people with Parkinson&Amp;#39;s Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Parkinson&Amp;#39;s Disease
What is being tested?
Hydroxychloroquine (HCQ)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
9 Jun 2025to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 4E9

Other trials in Canada

About this study

Official title: TALLman Family Energizes Research To Help Alleviate Neuroinflammation in Parkinson's Disease - "TALLER THAN PD." A Phase 2 Futility Study to Evaluate the Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Early Treated Parkinson's Disease

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.

Read the detailed description

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

Being tested
Hydroxychloroquine (HCQ)
Keywords
Hydroxychloroquine, Neuroinflammation, Neuroprotection, Parkinson
Medical subject headings
Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydroxychloroquine (HCQ)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.

Study groups in NCT06816810
Study groupRoleWhat they receive
Hydroxychloroquine Treatment for Early Parkinson's Disease (HCQ-PD)ExperimentalThis 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.
Receives: Drug: Hydroxychloroquine (HCQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    All participants exposed to HCQ at least once will be assessed for:

    • Incidence and severity of treatment-emergent adverse events (TEAEs)
    • Relationship of TEAEs to HCQ
    • Percentage of discontinuations due to adverse events (AEs)

    Measured: 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

    Another primary clinical outcome is assess change in motor symptom severity, specifically using the movement disorder society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. A ≥4-point increase (one standard deviation) over 48 weeks will be used as a threshold to assess whether HCQ delays clinical motor progression of PD when compared to historical controls.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. MDS-UPDRS Part III will be evaluated at baseline, 24 weeks and 48 weeks.

Secondary outcomes (7)

  1. Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using CGI-C Scale

    The Clinical Global Impression of Change (CGI-C) scale assesses the clinician's perception of the change in a patient's condition. It ranges from 1 (very much improved) to 7 (very much worse). A score of 1-3 indicates improvement, while a score of 5-7 indicates worsening of the condition. This study will identify the number of participants with worsening CGI-C scale by the end of the study.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. CGI-C will be evaluated at baseline, 24 weeks and 48 weeks.

  2. Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using CGI-S Scale

    The Clinical Global Impression-Severity (CGI-S) scale will be used to assess the severity of Parkinson's disease symptoms based on clinician judgment. The scale ranges from 1 (normal, not at all ill) to 7 (extremely ill). A higher score indicates more severe symptoms. A reduction in score will indicate an improvement in disease severity. This study will identify the number of participants with worsening CGI-S scale by the end of the study.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. CGI-S will be evaluated at baseline, 24 weeks and 48 weeks.

  3. Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using PGI-S Scale

    The Patient Global Impression-Severity (PGI-S) scale measures the patient's assessment of the severity of their Parkinson's disease symptoms at the time of the assessment. The scale ranges from 1 (not at all ill) to 7 (extremely ill). A higher score indicates greater severity, and a decrease in score over time indicates improvement. This study will identify the number of participants with worsening PGI-S scale by the end of the study.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. PGI-S will be evaluated at baseline, 24 weeks and 48 weeks.

  4. Efficacy of Hydroxychloroquine (HCQ) in Delaying Clinical PD Progression Using PGI-C Scale

    The Patient Global Impression of Change (PGI-C) measures the patient's own perception of how much their condition has changed since the beginning of the study. The scale ranges from 1 (very much improved) to 7 (very much worse), with 1-3 indicating improvement and 5-7 indicating worsening. This study will identify the number of participants with worsening PGI-C scale by the end of the study.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. PGI-C will be evaluated at baseline, 24 weeks and 48 weeks.

  5. Change in Quality of Life (QoL) as assessed by the PDQ-8

    The Parkinson's Disease Questionnaire-8 (PDQ-8) will be used to assess changes in quality of life (QoL) over the 48-week treatment period. The PDQ-8 is a shorter version of the PDQ-39 and includes 8 items measuring physical functioning, emotional well-being, and social participation. Scores range from 0 to 32, where a higher score indicates worse quality of life. A decrease in the score reflects an improvement in QoL.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. QoL will be evaluated at baseline, 24 weeks and 48 weeks.

  6. Efficacy of Hydroxychloroquine (HCQ) Using Change in Modified Hoehn and Yahr Scale

    The Modified Hoehn and Yahr Scale is widely recognized for tracking the progression of Parkinson's disease and is crucial for evaluating treatment effects on motor symptoms. It will measure disease severity in Parkinson's patients, ranging from 0 (no signs of disease) to 5 (wheelchair-bound or bedridden unless aided). A decrease in score indicates an improvement in motor function and disease severity.

    Measured: Throughout enrollment to the end of treatment at 48 weeks. Modified Hoehn and Yahr Scale will be evaluated at baseline, 24 weeks and 48 weeks.

  7. Efficacy of Hydroxychloroquine (HCQ) in Slowing Clinical Disease Progression as Assessed by the MDS-UPDRS

    Movement Disorder Society-Unified Parkinson's Disease Rating Scale ( MDS-UPDRS) is a comprehensive scale for assessing both motor and non-motor aspects of Parkinson's disease. The efficacy of HCQ in slowing clinical disease progression will be measured by the change from baseline to Week 48 in various MDS-UPDRS sub-scales:

    MDS-UPDRS Part I score (Non-motor aspects of PD) MDS-UPDRS Part II score (Motor experiences of daily living) MDS-UPDRS Part III score (Motor examination) MDS-UPDRS Part II + Part III (Tremor items) MDS-UPDRS Part II + Part III (Non-Tremor items)

    Measured: Throughout enrollment to the end of treatment at 48 weeks. MDS-UPDRS will be evaluated at baseline, 24 weeks and 48 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start9 Jun 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06816810
Sponsor's protocol ID
Taller Than PD
Status last verified
Oct 2026
First submitted
14 Jan 2025
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25546558

  • 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.

    PubMed 33635229

  • 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.

    PubMed 33555429

  • 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.

    PubMed 30797853

  • 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.

    PubMed 29662921

  • 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.

    PubMed 32610165

  • Huang L, Li Q, Shah SZA, Nasb M, Ali I, Chen B, Xie L, Chen H. Efficacy and safety of ultra-short wave diathermy on COVID-19 pneumonia: a pioneering study. Front Med (Lausanne). 2023 Jun 5;10:1149250. doi: 10.3389/fmed.2023.1149250. eCollection 2023.

    PubMed 37342496

  • 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.

    PubMed 33583332

  • 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.

    PubMed 11689198

  • 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.

    PubMed 26391537

  • 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.

    PubMed 35645965

  • 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.

    PubMed 32652194

  • 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.

    PubMed 36038917

  • 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.

    PubMed 28219513

  • 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.

    PubMed 29652656

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxychloroquine (HCQ) in people with Parkinson&Amp;#39;s Disease, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Throughout enrollment (4 weeks of screening) to the end of treatment at 48 weeks and 4-week safety follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06816810, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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