Parkinson DiseasePhase 2PD NilotinibNCT02954978

Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease

A Phase 2 study testing Nilotinib 150mg oral capsule [Tasigna] and Nilotinib 300mg oral capsule [Tasigna] in people with Parkinson Disease and Parkinsons Disease With Dementia, run by Georgetown 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

Search all trials

Trial summary

Who is it for?: Ages 40 to 90 years
Conditions the study is for: Parkinson Disease, Parkinsons Disease With Dementia
What is being tested?: Nilotinib 150mg oral capsule [Tasigna] and Nilotinib 300mg oral capsule [Tasigna]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: 1 siteUnited States
Study dates: Jan 2017to Jul 2020
Phase: Phase 2
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 40 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Written informed consent
Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR).
Patients between the age of 40-90 years, medically stable
Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
PD subjects with MoCA ≥ 22
2.5 ≥Hoehn and Yahr stage ≤3

Show all 10Show fewer

No mono-amine oxidase (MAO)-B inhibitors (Selegeline or rasagiline) are allowed at least 6 weeks before enrollment
Must be medically stable on 800mg Levodopa daily for at least 4 weeks
QTc interval 350-460 ms, inclusive
Participants must be willing to undergo LP at baseline and 12 months after treatment

Who cannot join

Patients with hypokalemia, hypomagnesaemia, or long QT syndrome- QTc≥461 ms
Concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infraction or cardiac failure, angina, arrhythmia
History or presence of cardiac conditions including:
Cardiovascular or cerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke)
Congestive heart failure
First, second- or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances

Show all 26Show fewer

Any history of Torsade de Pointes
Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial:
Treatment with Class IA or III antiarrhythmic drugs (e.g. quinidine)
Treatment with QT prolonging drugs (www.crediblemeds.org)- excluding Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. Citalopram, Paxil, Zoloft, Cymbalta, Sertraline, etc...)
Strong CYP3A4 inhibitors (including grapefruit juice). The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) must be avoided. Grapefruit products may also increase serum concentrations of Nilotinib. Should treatment with any of these agents be required, therapy with Nilotinib should be interrupted.
Anticoagulants, including Coumadin (warfarin), heparin, enoxaparin, daltiparin, xarelto, etc.
St. John's Wort and the concomitant use of strong other CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) must be avoided since these agents may reduce the concentration of Nilotinib.
Abnormal liver function defined as AST and/or ALT > 100% the upper limit of the normal
Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal
History of HIV, clinically significant chronic hepatitis, or other active infection
Females must not be lactating, pregnant or with possible pregnancy
Medical history of liver or pancreatic disease
Clinical signs indicating syndromes other than idiopathic PD, including corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, Babinski sign
Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality
Active neoplastic disease, history of cancer five years prior to screening, including breast cancer (history of skin melanoma or stable prostate cancer are not exclusionary)
Contraindications to LP: prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, platelets < 100,000, use of Coumadin/warfarin, or history of a bleeding disorder
Must not be on any immunosuppressant medications (e.g. IVig)
Must not be enrolled as an active participant in another clinical study
Diagnosis of DLB

Trial locations and contacts

1 site in 1 country.

United States1 site

MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease

Parkinson's disease (PD) is the second most common neurodegenerative disorder causing motor and non-motor symptoms. PD is characterized by death of dopaminergic (DA) neurons in the substantia nigra (SN) pars compacta and formation of inclusions known as Lewy bodies (LBs) that primarily contain aggregated alpha-Synuclein. Nilotinib (Tasigna®, AMN107, Novartis, Switzerland) is approved by U.S. Food and Drug Administration (FDA) and is well tolerated for CML treatment at oral doses of 600-800mg daily. Nilotinib penetrates the brain and promotes autophagic degradation of alpha-Synuclein and p-Tau, leading to survival of DA neurons and improvement of motor function in PD models. For these studies, Nilotinib (1-10mg/kg daily) was used at significantly less than the clinically approved dose (up to 1200mg daily) in CML.

Read the detailed description

Based on strong pre-clinical evidence of the effects of Nilotinib on neurodegenerative pathologies, including autophagic clearance of neurotoxic proteins, neurotransmitters (dopamine and glutamate), immunity and behavior, the investigators conducted an open label pilot clinical trial in advanced PD with dementia (PDD) and Dementia with Lewy Body (DLB) (stage 3-4) patients. Participants (N=12) were randomized 1:1 to once daily oral dose of 150mg and 300mg Nilotinib for 6 months. The investigators' data suggest that Nilotinib penetrates the brain and inhibits CSF Abelson (Abl) activity via reduction of phosphorylated Abl in agreement with pre-clinical data. Several studies show that CSF alpha-Synuclein and Abeta42 are decreased and CSF total Tau and p-Tau are increased in PD and DLB. The investigators' data show attenuation of loss of CSF alpha-Synuclein and Abeta40/42 with 300mg (50% of the CML dose) compared to 150mg Nilotinib after 6 months treatment. CSF homovanillic acid (HVA), which is an end by-product of dopamine, is significantly increased; and CSF total Tau and p-Tau are significantly reduced (N=5, P<0.05) with 300mg Nilotinib between baseline and 6 months treatment. Despite the reduction of L-Dopa replacement therapies in our study, UDPRS I-IV scores improved with 150mg (3.5 points) and 300mg (11 points) from baseline to 6 months and worsened (13.7 points and 11.4 points) after 3 months withdrawal of 150mg and 300mg, respectively. Other non-motor functions e.g. constipation was resolved in all patients and cognition was also improved (3.5 points) using both the Mini-Mental Status Exam (MMSE) or the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-Cog) between baseline and 6 months. MMSE scores returned to baseline after 3 months of Nilotinib withdrawal. These data are very compelling to evaluate the effects of Nilotinib in a phase II, randomized, double-blind, placebo-controlled trial in patients with PD.

Conditions: Parkinson Disease, Parkinsons Disease With Dementia
Being tested: Placebo Oral Capsule, Nilotinib 150mg oral capsule [Tasigna], Nilotinib 300mg oral capsule [Tasigna]
Medical subject headings: Parkinson Disease

What participants receive

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

Placebo Oral CapsuleDrug
Also called Placebo
25 patients in group 1 will receive Placebo ("sugar pill") one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
Nilotinib 150mg oral capsule [Tasigna]Drug
Also called Nilotinib low dose
25 patients in group 2 will receive 150mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
Nilotinib 300mg oral capsule [Tasigna]Drug
Also called Nilotinib high dose
25 patients in group 3 will receive 300mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.

Study groups in NCT02954978
Study group	Role	What they receive
Placebo	Placebo comparator	Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 1 will receive the placebo ("sugar pill") one (1) capsule by mouth once daily (taken without a meal) for 12 months and 3 months follow up. Receives: Drug: Placebo Oral Capsule
Nilotinib 150mg	Active comparator	Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 2 will receive 150mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up. Receives: Drug: Nilotinib 150mg oral capsule [Tasigna]
Nilotinib 300mg	Active comparator	Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 3 will receive 300mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up. Receives: Drug: Nilotinib 300mg oral capsule [Tasigna]

What is being measured

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

Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events
Safety will be measured by assessing number of participants with adverse events (AEs) and serious adverse events (SAEs) deemed to be possibly, probably, or definitely related to the study drug.
Measured: 12 months

Secondary outcomes (3)

Biomarker Analysis
Quantification of homovanillic acid (HVA) and 3,4,-dihydroxyphenylacetic acid (DOPAC) in human CSF by ultra-high performance liquid chromatography with tandem mass spectrometry in cerebrospinal fluid at 12 months.
Measured: 12 months
Biomarker Analysis (Amyloid Markers) in Cerebral Spinal Fluid (CSF)
Quantification of alpha-synuclein (a-syn), oligomeric a-syn, phospho-Tau (181) (p-Tau(181)), and Total Tau (tTau) in human CSF by Enzyme-Linked Immunosorbent Assay (ELISA) at 12 months.
Measured: 12 months
Biomarker Analysis (Ratio of Amyloid Markers) in Cerebral Spinal Fluid (CSF)
Ratio of oligomeric a-syn to alpha-synuclein (a-syn), and phospho-Tau (181) (p-Tau(181)) to Total Tau (tTau) in human CSF at 12 months.
Measured: 12 months

Timeline

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

Jan 2017Jul 2020

First posted4 Nov 2016 (estimated)
Study startJan 2017
Primary completionMay 2020
Study completionJul 2020

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 (4)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 Georgetown 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02954978
Sponsor's protocol ID: IRB# 2016-0380
Acronym: PD Nilotinib
Status last verified: Jun 2026
First submitted: 1 Nov 2016
Last updated: 12 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Pagan F, Hebron M, Valadez EH, Torres-Yaghi Y, Huang X, Mills RR, Wilmarth BM, Howard H, Dunn C, Carlson A, Lawler A, Rogers SL, Falconer RA, Ahn J, Li Z, Moussa C. Nilotinib Effects in Parkinson's disease and Dementia with Lewy bodies. J Parkinsons Dis. 2016 Jul 11;6(3):503-17. doi: 10.3233/JPD-160867.
PubMed 27434297
Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
PubMed 40680102
Fowler AJ, Ahn J, Hebron M, Chiu T, Ayoub R, Mulki S, Ressom H, Torres-Yaghi Y, Wilmarth B, Pagan FL, Moussa C. CSF MicroRNAs Reveal Impairment of Angiogenesis and Autophagy in Parkinson Disease. Neurol Genet. 2021 Nov 12;7(6):e633. doi: 10.1212/NXG.0000000000000633. eCollection 2021 Dec.
PubMed 34786477
Pagan FL, Hebron ML, Wilmarth B, Torres-Yaghi Y, Lawler A, Mundel EE, Yusuf N, Starr NJ, Anjum M, Arellano J, Howard HH, Shi W, Mulki S, Kurd-Misto T, Matar S, Liu X, Ahn J, Moussa C. Nilotinib Effects on Safety, Tolerability, and Potential Biomarkers in Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2020 Mar 1;77(3):309-317. doi: 10.1001/jamaneurol.2019.4200.
PubMed 31841599

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?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease
ClinicalTrials.gov ID: NCT02954978
Acronym / sponsor ID: PD Nilotinib / IRB# 2016-0380
Conditions: Parkinson Disease, Parkinsons Disease With Dementia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Georgetown UniversityUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: May 2020 (actual)
Study completion: Jul 2020 (actual)
First posted: 4 Nov 2016 (estimated)
Results: Posted 12 Jun 2026

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo Oral CapsuleOut of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 1 will receive the placebo ("sugar pill") one (1) capsule by mouth once daily (taken without a meal) for 12 months and 3 months follow up.
Nilotinib 150mg	Active comparator	Drug: Nilotinib 150mg oral capsule [Tasigna]Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 2 will receive 150mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
Nilotinib 300mg	Active comparator	Drug: Nilotinib 300mg oral capsule [Tasigna]Out of seventy five (75) participants that will be recruited and randomly assigned 1:1:1 to the three (3) groups (arms), 25 patients in group 3 will receive 300mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.

Who may qualify

Ages: 40 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Written informed consent
Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR).
Patients between the age of 40-90 years, medically stable
Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
PD subjects with MoCA ≥ 22

Key exclusion criteria (26 listed)

Patients with hypokalemia, hypomagnesaemia, or long QT syndrome- QTc≥461 ms
Concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infraction or cardiac failure, angina, arrhythmia
History or presence of cardiac conditions including:
Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial:
Abnormal liver function defined as AST and/or ALT > 100% the upper limit of the normal

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
Placebo Oral CapsuleAlso: Placebo25 patients in group 1 will receive Placebo ("sugar pill") one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.	Drug	Placebo
Nilotinib 150mg oral capsule [Tasigna]Also: Nilotinib low dose25 patients in group 2 will receive 150mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.	Drug	Nilotinib 150mg
Nilotinib 300mg oral capsule [Tasigna]Also: Nilotinib high dose25 patients in group 3 will receive 300mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.	Drug	Nilotinib 300mg

Primary outcome

Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events
Time frame: 12 months
Safety will be measured by assessing number of participants with adverse events (AEs) and serious adverse events (SAEs) deemed to be possibly, probably, or definitely related to the study drug.

3 secondary outcomes

Biomarker Analysis
Time frame: 12 months
Biomarker Analysis (Amyloid Markers) in Cerebral Spinal Fluid (CSF)
Time frame: 12 months
Biomarker Analysis (Ratio of Amyloid Markers) in Cerebral Spinal Fluid (CSF)
Time frame: 12 months

Results and safety

Results posted to the registry on 12 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	25	22
Nilotinib 150mg	25	23
Nilotinib 300mg	25	19

Primary outcome: Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events

Time frame: 12 months. Number. Unit: events

Measure	Placebo n = 25	Nilotinib 150mg n = 25	Nilotinib 300mg n = 25
Adverse Events	65	71	57
Severe Adverse Events	4	6	12

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for 15 months per patient.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 25 (12%)	23 of 25 (92%)	0 of 25
Nilotinib 150mg	5 of 25 (20%)	25 of 25 (100%)	0 of 25
Nilotinib 300mg	9 of 25 (36%)	23 of 25 (92%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27434297Pagan F, Hebron M, Valadez EH, Torres-Yaghi Y, Huang X, Mills RR, Wilmarth BM, Howard H, Dunn C, Carlson A, Lawler A, Rogers SL, Falconer RA, Ahn J, Li Z, Moussa C. Nilotinib Effects in Parkinson's disease and Dementia with Lewy bodies. J Parkinsons Dis. 2016 Jul 11;6(3):503-17. doi: 10.3233/JPD-160867.
Derived from this study: PubMed 40680102Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.
Derived from this study: PubMed 34786477Fowler AJ, Ahn J, Hebron M, Chiu T, Ayoub R, Mulki S, Ressom H, Torres-Yaghi Y, Wilmarth B, Pagan FL, Moussa C. CSF MicroRNAs Reveal Impairment of Angiogenesis and Autophagy in Parkinson Disease. Neurol Genet. 2021 Nov 12;7(6):e633. doi: 10.1212/NXG.0000000000000633. eCollection 2021 Dec.
Derived from this study: PubMed 31841599Pagan FL, Hebron ML, Wilmarth B, Torres-Yaghi Y, Lawler A, Mundel EE, Yusuf N, Starr NJ, Anjum M, Arellano J, Howard HH, Shi W, Mulki S, Kurd-Misto T, Matar S, Liu X, Ahn J, Moussa C. Nilotinib Effects on Safety, Tolerability, and Potential Biomarkers in Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2020 Mar 1;77(3):309-317. doi: 10.1001/jamaneurol.2019.4200.
https://sites.google.com/a/georgetown.edu/moussa-lab/home3Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Fernando L Pagan, MD principal investigator

Georgetown 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 10 inclusion and 26 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 12 Jun 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 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2026). 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?

Safety Will be Measured by Number of Participants Experiencing the Occurrence of Adverse Events (time frame: 12 months). 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 NCT02954978, which also lists 4 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 12 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.