Parkinson DiseaseNCT02445651

Physiological Effects of Nutritional Support in Patients With Parkinson's Disease

A study testing Intravenous and Oral n-acetyl cysteine and Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin in people with Parkinson Disease and Idiopathic Parkinson Disease, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Parkinson Disease, Idiopathic Parkinson Disease
What is being tested?: Intravenous and Oral n-acetyl cysteine and Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Mar 2014to 4 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical Diagnosis of Parkinson's disease
Subject is between 30 - 80 years of age
Subject has a Hoehn and Yahr score of I - II inclusive
Subject is on stable or on antiparkinsonian medication for at least a month
Women of Childbearing potential will confirm a negative pregnancy test

Who cannot join

Subject is allergic to iodine, cobalt, or any of the supplements that will be given in the study
Subject has had previous brain surgery
Subject has a score of 25 or less on Mini-Mental Status examination
Subject is wheelchair-bound or bed-ridden; non ambulatory
Subject has intracranial abnormalities that may complicate interpretation of the brain scans(e.g., stroke, tumor, vascular abnormality affecting the target area)
Subject has a history of head trauma with loss of consciousness greater than 48 hours

Show all 22Show fewer

Subject has any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of parkinsonian syndrome symptoms, or with any of the study assessments including the SPECT imaging.
Subject has evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study
Subject has a current alcohol or drug abuse
Subject is pregnant or lactating
Subject is enrolled in active clinical (drug or device) trial within the prior 30 days
Subject is pending surgery during the course of the study
History of very low blood pressure
History of thrombocytopenia or clotting disorders
Cancer patients receiving active chemotherapy
History of active gallstone problems or a bile duct obstruction
History of uncontrolled diabetes, asthma, gastroesophageal reflex disease, or thyroid
History of severe kidney disease (if the patient reports this problem, a serum creatinine will be checked to assess GFR; if it is less than 30, the patient will be excluded)
History of Leber's disease, a hereditary eye disease
History of uncontrolled hypercalcemia
History of active sarcoidosis, histoplasmosis, or lymphoma
Patients taking medication that might interact with the supplements involved in this study will be evaluated on a case-by-case basis by PI study physician

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more than a million Americans. It's most prominent pathology is the degeneration of dopaminergic neurons in the brain. It is believed that oxidative stress and inflammation play an important role in the pathophysiology of Parkinson's disease as well.

The object of this study is to evaluate whether nutritional supplementation with oral and IV N acetyl cysteine compounds, that have been shown to have either anti- inflammatory, or antioxidant effects, might support brain function in patients with Parkinson's disease, particularly in regards to the dopamine system. Enrolled patients will be randomly assigned to receive oral and intravenous (IV) n-acetyl cysteine (NAC), a control group of standard PD care, or an oral supplement group who will receive Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin. (Please note, the Oral Supplements arm, was amended and not included in analysis.

This study utilized Ioflupane (DaTscan) single photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD. Subjects received a DaTSCAN and MRS initially and after completing oral and IV NAC regimen. Subjects in the control group received pre and post DaTScans and MRS and similar evaluations to the Dietary Supplement oral and IV NAC group.

Read the detailed description

The first arm of this study received intravenous and oral NAC, which is a strong antioxidant that increases brain glutathione, which may be beneficial in PD. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. NAC is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC, such as its potential to counteract intracellular damage that leads to dopaminergic neuron death. It also has the potential to reduce markers of oxidative damage, protect against dopamine cell death from MPTP toxicity, and to increase glutathione in blood, which might be useful in preventing oxidative damage in PD patients.

The second arm was a waitlist control group who received no intervention. The control group continued to receive clinical standard of care treatment for PD care provided by their neurologist.

A third arm of the study was an oral supplement group who received Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin.This oral supplement group continued to receive clinical standard of care treatment for PD provided by their neurologist.

The protocol was amended to include only the NAC arm and the standard of care waitlist control groups.

Conditions: Parkinson Disease, Idiopathic Parkinson Disease
Being tested: Intravenous and Oral n-acetyl cysteine, Control group, Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin
Keywords: Integrative Medicine, Alternative Medicine, Complementary Medicine, Parkinson's disease, Neurodegenerative Diseases, Idiopathic Parkinson's disease, Single Photon Emission Computed Tomography (SPECT), Central Nervous System Diseases, Movement Disorders, Nervous System Diseases, Brain Diseases, Oral supplements, N-acetyl cysteine
Medical subject headings: Parkinson Disease, Neurodegenerative Diseases, Central Nervous System Diseases, Movement Disorders, Nervous System Diseases, Brain Diseases

What participants receive

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

Intravenous and Oral n-acetyl cysteineDietary supplement
Control groupOther
Standard of Care
Oral Supplements: Baicalin, Ganoderma, Omega 3 and CurcuminDietary supplement
Baicalin 400mg (Narula Reasearch) 2 x per day Curcumin Phytosome 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Frequency: over one hour 1 x per week for 90 days ± 30 days

Study groups in NCT02445651
Study group	Role	What they receive
Oral and IV N acetyl Cysteine Cohort	Experimental	Administration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of D5W, frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 600 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered) Receives: Dietary Supplement: Intravenous and Oral n-acetyl cysteine
Control Cohort	Active comparator	Standard of Care Treatment Receives: Other: Control group
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin	Active comparator	Baicalin 400mg (Narula Reasearch) 2 x per day Curcumin Phytosome 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Frequency: over one hour 1 x per week for 90 days ± 30 days The protocol was amended; this cohort was not included in analysis that was reported in results. Receives: Dietary Supplement: Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin

What is being measured

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

Distribution Volume Ratio
Distribution Volume Ratio reflects Iofluvane absorption by the dopamine transporters (Dopamine Uptake) that reflects binding in the dopamine transporter (DAT) overall. Striatal Binding Ratio in the regions of interest (ROI), caudate, putamen, and midbrain Serotonin Transporter (SERT) binding and Dopamine Transporter (5-HTT) Binding was measured during Single Photon Emission Computed Tomography (SPECT) Brain Imaging with DATScan (Iofluvane). Regions of interest in the caudate, putamen and in midbrain SERT binding are affected in Parkinson's Disease. Less dopamine transporter binding (lower number) indicates less activated dopamine transporters (worse); more binding (higher number) indicates more binding (better), thus, measuring the overall health of the dopaminergic system in the brain.
Analysis was completed only for the Oral and IV N acetyl Cysteine Cohort and Control Cohort; the Oral Supplements arm of the study was discontinued and not included in analysis
Measured: Baseline and 90 ± 30 days

Timeline

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

Mar 20144 Aug 2022

First posted15 May 2015 (estimated)
Study startMar 2014
Primary completion4 Aug 2022
Study completion4 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: To evaluate whether IV/oral N acetyl cysteine, compared to standard of care ,no intervention, (or the discontinued oral supplementation arm) helps support dopamine function in the brains of patients with Parkinson's disease measured using Iofluvane (DATScan); clinical symptoms will be measured.
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445651
Sponsor's protocol ID: 14D.141
Status last verified: Nov 2025
First submitted: 23 Jan 2015
Last updated: 15 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.

Publications

Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
PubMed 27309537
Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Bazzan AJ, Zhong L, Bowens BK, Chervoneva I, Intenzo C, Newberg AB. N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease. Clin Pharmacol Ther. 2019 Oct;106(4):884-890. doi: 10.1002/cpt.1548. Epub 2019 Jul 17.
PubMed 31206613

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT02445651
Acronym / sponsor ID: 14D.141
Conditions: Parkinson Disease, Idiopathic Parkinson Disease
Keywords: Integrative Medicine, Alternative Medicine, Complementary Medicine, Parkinson's disease, Neurodegenerative Diseases, Idiopathic Parkinson's disease, Single Photon Emission Computed Tomography (SPECT), Central Nervous System Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Study start: Mar 2014 (actual)
Primary completion: 4 Aug 2022 (actual)
Study completion: 4 Aug 2022 (actual)
First posted: 15 May 2015 (estimated)
Results: Posted 15 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The second arm was a waitlist control group who received no intervention. The control group continued to receive clinical standard of care treatment for PD care provided by their neurologist.

The protocol was amended to include only the NAC arm and the standard of care waitlist control groups.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: To evaluate whether IV/oral N acetyl cysteine, compared to standard of care ,no intervention, (or the discontinued oral supplementation arm) helps support dopamine function in the brains of patients with Parkinson's disease measured using Iofluvane (DATScan); clinical symptoms will be measured.

Arm	Type	Receives
Oral and IV N acetyl Cysteine Cohort	Experimental	Dietary Supplement: Intravenous and Oral n-acetyl cysteineAdministration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of D5W, frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 600 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)
Control Cohort	Active comparator	Other: Control groupStandard of Care Treatment
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin	Active comparator	Dietary Supplement: Oral Supplements: Baicalin, Ganoderma, Omega 3 and CurcuminBaicalin 400mg (Narula Reasearch) 2 x per day Curcumin Phytosome 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Frequency: over one hour 1 x per week for 90 days ± 30 days The protocol was amended; this cohort was not included in analysis that was reported in results.

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Clinical Diagnosis of Parkinson's disease
Subject is between 30 - 80 years of age
Subject has a Hoehn and Yahr score of I - II inclusive
Subject is on stable or on antiparkinsonian medication for at least a month
Women of Childbearing potential will confirm a negative pregnancy test

Key exclusion criteria (22 listed)

Subject is allergic to iodine, cobalt, or any of the supplements that will be given in the study
Subject has had previous brain surgery
Subject has a score of 25 or less on Mini-Mental Status examination
Subject is wheelchair-bound or bed-ridden; non ambulatory
Subject has intracranial abnormalities that may complicate interpretation of the brain scans(e.g., stroke, tumor, vascular abnormality affecting the target area)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravenous and Oral n-acetyl cysteine	Dietary supplement	Oral and IV N acetyl Cysteine Cohort
Control groupStandard of Care	Other	Control Cohort
Oral Supplements: Baicalin, Ganoderma, Omega 3 and CurcuminBaicalin 400mg (Narula Reasearch) 2 x per day Curcumin Phytosome 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Frequency: over one hour 1 x per week for 90 days ± 30 days	Dietary supplement	Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin

Primary outcome

Distribution Volume Ratio
Time frame: Baseline and 90 ± 30 days
Distribution Volume Ratio reflects Iofluvane absorption by the dopamine transporters (Dopamine Uptake) that reflects binding in the dopamine transporter (DAT) overall. Striatal Binding Ratio in the regions of interest (ROI), caudate, putamen, and midbrain Serotonin Transporter (SERT) binding and Dopamine Transporter (5-HTT) Binding was measured during Single Photon Emission Computed Tomography (SPECT) Brain Imaging with DATScan (Iofluvane). Regions of interest in the caudate, putamen and in midbrain SERT binding are affected in Parkinson's Disease. Less dopamine transporter binding (lower number) indicates less activated dopamine transporters (worse); more binding (higher number) indicates more binding (better), thus, measuring the overall health of the dopaminergic system in the brain. Analysis was completed only for the Oral and IV N acetyl Cysteine Cohort and Control Cohort; the Oral Supplements arm of the study was discontinued and not included in analysis

Results and safety

Results posted to the registry on 15 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral and IV N acetyl Cysteine Cohort	28	28
Control Cohort	14	14
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 Fatty Acids and Curcumin	9	9

Primary outcome: Distribution Volume Ratio

Time frame: Baseline and 90 ± 30 days. Mean (95% Confidence Interval). Unit: Distribution volume ratios

Measure	Oral and IV N acetyl Cysteine Cohort n = 28	Control Cohort n = 14	Oral Supplements Cohort: Baicalin, Ganoderma, Omega 3 and Curcumin n = 9
Degree of DAT binding Caudate DAT-binding pre	2.65 (2.5 to 2.8)	2.70 (2.49 to 2.92)	2.96 (2.04 to 3.69)
Degree of DAT binding Caudate DAT-binding post	2.74 (2.59 to 2.89)	2.65 (2.44 to 2.86)	2.93 (2.00 to 3.53)
Degree of DAT binding Putamen DAT-binding pre	1.68 (1.54 to 1.83)	1.84 (1.63 to 2.05)	1.83 (1.40 to 2.50)
Degree of DAT binding Putamen DAT-binding post	1.82 (1.67 to 1.97)	1.73 (1.52 to 1.94)	1.80 (1.48 to 2.33)
Degree of DAT binding Caudate pre-post change	0.092 (0.013 to 0.170)	-0.059 (-0.171 to 0.052)	-0.031 (-0.381 to .232)
Degree of DAT binding Putamen pre-post change	0.135 (0.056 to 0.214)	-0.110 (-0.222 to 0.001)	-0.032 (-0.463 to 0.190)
Degree of SERT binding Midbrain SERT binding pre measures	1.48 (1.41 to 1.55)	1.59 (1.49 to 1.69)	1.55 (1.32 to 1.81)
Degree of SERT binding Midbrain SERT binding pre measures Midbrain SERT binding post measures	1.62 (1.55 to 1.69)	1.48 (1.38 to 1.57)	1.54 (1.43 to 1.65)

Oral and IV N acetyl Cysteine Cohort vs Control Cohort: p = 0.05, 5-10% improvement in the oral and IV NAC
Oral and IV N acetyl Cysteine Cohort vs Control Cohort: p = 0.05, t-test, 2 sided
Oral and IV N acetyl Cysteine Cohort vs Control Cohort: p = 0.05, t-test, 2 sided

Population analysed: 51 participants were enrolled for full course of the study. Using a 2:1 randomization technique, 28 subjects, 14 men and 14 women, were randomized to the NAC arm; 14 subjects, 7 men and 7 women, were assigned to the waitlist control arm. 9 participants in the Oral Supplement arm. The Oral supplement arm of the study was discontinued to focus on a comparison of NAC and controls. Swallowing multiple oral supplements was difficult for persons with Parkinson's disease.

Adverse events

Time frame: Through study completion, an average of 4 months. The adverse event data was collected and monitored throughout the entire duration of the study (8 years, 4 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral and IV N acetyl Cysteine Cohort	0 of 28 (0%)	0 of 28 (0%)	28 of 28
Control Cohort	0 of 14 (0%)	0 of 14 (0%)	14 of 14
Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin	0 of 9 (0%)	0 of 9 (0%)	9 of 9

Limitations and caveats (from the sponsor): The study was amended to discontinue the oral supplement group to focus on the Oral and IV Acetyl cysteine and the controls groups. Swallowing oral supplements was difficult. The randomization changed from 2:2:1 to a 1:1 ratio for enrollment in the remaining 2 groups. In error, the statistical analysis plan was not updated in the amended protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27309537Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.
Background: PubMed 31206613Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Bazzan AJ, Zhong L, Bowens BK, Chervoneva I, Intenzo C, Newberg AB. N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease. Clin Pharmacol Ther. 2019 Oct;106(4):884-890. doi: 10.1002/cpt.1548. Epub 2019 Jul 17.
Individual participant dataSharing planned: Yes. After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel A Monti, MD,MBA principal investigator

Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 22 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: finished, as of the sponsor's last update on 15 Dec 2025. 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 United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Distribution Volume Ratio (time frame: Baseline and 90 ± 30 days). 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 NCT02445651, which also lists 2 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 15 Dec 2025.