Diabetic NeuropathiesPhase 2NCT04088929

The Use of a Water Soluble Under the Tongue (Sublingual) CBD Tablet for Treating Pain Associated With Diabetic Peripheral Neuropathy

A Phase 2 study testing CBD in people with Diabetic Neuropathies, run by Pure Green 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

Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Diabetic Neuropathies
What is being tested?: CBD
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2019to 1 Dec 2019
Phase: Phase 2
Are there results?: None posted in the registry

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is at least 21 years of age;
Subject has a diagnosis of chronic diabetic neuropathic pain condition as determined by the subject's health care or allied health provider for which medications other than cannabis, cannabinoids, or cannabis-based medicines are currently utilized;
Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;
If female, subject is postmenopausal (> 1 year), surgically sterile, or practicing an approved method of birth control throughout the study and for 5 months (150 days) after the last dose of study drug;
If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;
Subject is willing and able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
Subject has access to a smart phone and knows how to use smart phone applications.

Who cannot join

Subject is pregnant or lactating;
Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;
Subject has a known allergy to active or inert ingredients of Pure Green tablets;
Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;
Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS));
Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 30 days prior to this study., and does not promise to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study;

Show all 11Show fewer

Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
Subject has shortness of breath associated with allergies;
Subject has uncontrolled asthma;
Subject has a fever and/or productive cough;
Subject does not have access to a smart phone or does not know how to use a smart phone application.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dr. Nakadar's Office
Sterling Heights, Michigan, 48310

Other trials in United States

About this study

Official title: A Dose Controlled Diabetic Neuropathic Pain Study Using Non-Intoxicating Cannabidiol in a Rapidly Dissolvable Sublingual Tablet

Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.

Conditions: Diabetic Neuropathies
Being tested: CBD
Keywords: Pain, Neuropathy, Neuropathic Pain, Diabetes
Medical subject headings: Diabetic Neuropathies, Pain, Neuralgia, Diabetes Mellitus

What participants receive

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

CBDDrug
A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.

Study groups in NCT04088929
Study group	Role	What they receive
CBD for Treatment of Diabetic Neuropathic Pain	Experimental	Patients are instructed to take 3 total tablets a day, under the tongue, six hours apart for three weeks. Patients are to enter their pain scale score into the smartphone app as instructed during the initial site visit. Patients are to enter into the notes section of the app any additional information such as side effects (positive or negative), medication changes. Receives: Drug: CBD

What is being measured

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

Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
To evaluate the safety and efficacy of Pure Green CBD sublingual tablets for the treatment of chronic diabetic neuropathic pain patients by evaluating their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 5.
Measured: Three Weeks

Secondary outcomes (4)

Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
To evaluate the impact of Pure Green CBD sublingual tablets on the quality of life of diabetic neuropathy patients measured by World Health Organization's quality of life questionnaire, . The objective is to examine quality of life metrics: overall quality of life and general health, physical health, psychological, social, and environment as measured on a 1-5 scale before and after the study.
Measured: Three Weeks
Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients
The Pittsburgh Sleep Quality Index will be used to compare pre and post Pure Green CBD tablet study on sleep changes. Patients will be asked questions before beginning the study and after completion.
Measured: Three weeks
Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients
The Hamilton Anxiety rating scale questionnaire will be administered before the study begins and after completion to examine the impact of Pure Green CBD tablets on anxiety in diabetic neuropathy pain patients. The scale of 0-4 will be used where 0 is no anxiety present and 4 is very severe anxiety.
Measured: Three Weeks
Impact on the use of sublingual tablets as the route of administration
To explore the impact of sublingual administration on patient compliance by evaluating the number of tablets taken per day as entered by the patients into the smart phone app.
Measured: Three Weeks

Timeline

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

30 Sep 20191 Dec 2019

First posted13 Sep 2019
Study start30 Sep 2019
Primary completion22 Nov 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04088929
Sponsor's protocol ID: PG-19-002
Status last verified: Sep 2019
First submitted: 10 Sep 2019
Last updated: 11 Dec 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev. 2003 Jan-Feb;19 Suppl 1:S2-8. doi: 10.1002/dmrr.360.
PubMed 12577252
Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
PubMed 22608666
Argoff CE, Cole BE, Fishbain DA, Irving GA. Diabetic peripheral neuropathic pain: clinical and quality-of-life issues. Mayo Clin Proc. 2006 Apr;81(4 Suppl):S3-11. doi: 10.1016/s0025-6196(11)61474-2.
PubMed 16608048
Sadosky A, Mardekian J, Parsons B, Hopps M, Bienen EJ, Markman J. Healthcare utilization and costs in diabetes relative to the clinical spectrum of painful diabetic peripheral neuropathy. J Diabetes Complications. 2015 Mar;29(2):212-7. doi: 10.1016/j.jdiacomp.2014.10.013. Epub 2014 Nov 8.
PubMed 25498300
Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care. 2003 Jun;26(6):1790-5. doi: 10.2337/diacare.26.6.1790.
PubMed 12766111
Singh R, Kishore L, Kaur N. Diabetic peripheral neuropathy: current perspective and future directions. Pharmacol Res. 2014 Feb;80:21-35. doi: 10.1016/j.phrs.2013.12.005. Epub 2013 Dec 25.
PubMed 24373831
Boulton AJ: Management of Diabetic Peripheral Neuropathy. Clinical Diabetes. 2005;23(1):9-15.
Wallace MS, Marcotte TD, Umlauf A, Gouaux B, Atkinson JH. Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy. J Pain. 2015 Jul;16(7):616-27. doi: 10.1016/j.jpain.2015.03.008. Epub 2015 Apr 3.
PubMed 25843054
Bridges D, Ahmad K, Rice AS. The synthetic cannabinoid WIN55,212-2 attenuates hyperalgesia and allodynia in a rat model of neuropathic pain. Br J Pharmacol. 2001 Jun;133(4):586-94. doi: 10.1038/sj.bjp.0704110.
PubMed 11399676
De Vry J, Denzer D, Reissmueller E, Eijckenboom M, Heil M, Meier H, Mauler F. 3-[2-cyano-3-(trifluoromethyl)phenoxy]phenyl-4,4,4-trifluoro-1-butanesulfonate (BAY 59-3074): a novel cannabinoid Cb1/Cb2 receptor partial agonist with antihyperalgesic and antiallodynic effects. J Pharmacol Exp Ther. 2004 Aug;310(2):620-32. doi: 10.1124/jpet.103.062836. Epub 2004 May 12.
PubMed 15140913
Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
PubMed 17296917
Ware MA, Wang T, Shapiro S, Robinson A, Ducruet T, Huynh T, Gamsa A, Bennett GJ, Collet JP. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):E694-701. doi: 10.1503/cmaj.091414. Epub 2010 Aug 30.
PubMed 20805210
Wilsey B, Marcotte T, Deutsch R, Gouaux B, Sakai S, Donaghe H. Low-dose vaporized cannabis significantly improves neuropathic pain. J Pain. 2013 Feb;14(2):136-48. doi: 10.1016/j.jpain.2012.10.009. Epub 2012 Dec 11.
PubMed 23237736
Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
PubMed 18403272
Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.
PubMed 19896326

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

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

All Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Controlled Diabetic Neuropathic Pain Study Using Non-Intoxicating Cannabidiol in a Rapidly Dissolvable Sublingual Tablet
ClinicalTrials.gov ID: NCT04088929
Acronym / sponsor ID: PG-19-002
Conditions: Diabetic Neuropathies
Keywords: Pain, Neuropathy, Neuropathic Pain, Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Pure GreenIndustry (pharma, biotech, devices)
Study start: 30 Sep 2019 (actual)
Primary completion: 22 Nov 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 13 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CBD for Treatment of Diabetic Neuropathic Pain	Experimental	Drug: CBDPatients are instructed to take 3 total tablets a day, under the tongue, six hours apart for three weeks. Patients are to enter their pain scale score into the smartphone app as instructed during the initial site visit. Patients are to enter into the notes section of the app any additional information such as side effects (positive or negative), medication changes.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject is at least 21 years of age;
Subject has a diagnosis of chronic diabetic neuropathic pain condition as determined by the subject's health care or allied health provider for which medications other than cannabis, cannabinoids, or cannabis-based medicines are currently utilized;
Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;
If female, subject is postmenopausal (> 1 year), surgically sterile, or practicing an approved method of birth control throughout the study and for 5 months (150 days) after the last dose of study drug;
If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;

Key exclusion criteria (11 listed)

Subject is pregnant or lactating;
Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;
Subject has a known allergy to active or inert ingredients of Pure Green tablets;
Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;
Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS));

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
CBDA water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.	Drug	CBD for Treatment of Diabetic Neuropathic Pain

Primary outcome

Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
Time frame: Three Weeks
To evaluate the safety and efficacy of Pure Green CBD sublingual tablets for the treatment of chronic diabetic neuropathic pain patients by evaluating their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 5.

4 secondary outcomes

Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
Time frame: Three Weeks
Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients
Time frame: Three weeks
Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients
Time frame: Three Weeks
Impact on the use of sublingual tablets as the route of administration
Time frame: Three Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
Background: PubMed 12577252Quattrini C, Tesfaye S. Understanding the impact of painful diabetic neuropathy. Diabetes Metab Res Rev. 2003 Jan-Feb;19 Suppl 1:S2-8. doi: 10.1002/dmrr.360.
Background: PubMed 22608666Callaghan BC, Cheng HT, Stables CL, Smith AL, Feldman EL. Diabetic neuropathy: clinical manifestations and current treatments. Lancet Neurol. 2012 Jun;11(6):521-34. doi: 10.1016/S1474-4422(12)70065-0. Epub 2012 May 16.
Background: PubMed 16608048Argoff CE, Cole BE, Fishbain DA, Irving GA. Diabetic peripheral neuropathic pain: clinical and quality-of-life issues. Mayo Clin Proc. 2006 Apr;81(4 Suppl):S3-11. doi: 10.1016/s0025-6196(11)61474-2.
Background: PubMed 25498300Sadosky A, Mardekian J, Parsons B, Hopps M, Bienen EJ, Markman J. Healthcare utilization and costs in diabetes relative to the clinical spectrum of painful diabetic peripheral neuropathy. J Diabetes Complications. 2015 Mar;29(2):212-7. doi: 10.1016/j.jdiacomp.2014.10.013. Epub 2014 Nov 8.
Background: PubMed 12766111Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care. 2003 Jun;26(6):1790-5. doi: 10.2337/diacare.26.6.1790.
Background: PubMed 24373831Singh R, Kishore L, Kaur N. Diabetic peripheral neuropathy: current perspective and future directions. Pharmacol Res. 2014 Feb;80:21-35. doi: 10.1016/j.phrs.2013.12.005. Epub 2013 Dec 25.
BackgroundBoulton AJ: Management of Diabetic Peripheral Neuropathy. Clinical Diabetes. 2005;23(1):9-15.
Background: PubMed 25843054Wallace MS, Marcotte TD, Umlauf A, Gouaux B, Atkinson JH. Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy. J Pain. 2015 Jul;16(7):616-27. doi: 10.1016/j.jpain.2015.03.008. Epub 2015 Apr 3.
Background: PubMed 11399676Bridges D, Ahmad K, Rice AS. The synthetic cannabinoid WIN55,212-2 attenuates hyperalgesia and allodynia in a rat model of neuropathic pain. Br J Pharmacol. 2001 Jun;133(4):586-94. doi: 10.1038/sj.bjp.0704110.
Background: PubMed 15140913De Vry J, Denzer D, Reissmueller E, Eijckenboom M, Heil M, Meier H, Mauler F. 3-[2-cyano-3-(trifluoromethyl)phenoxy]phenyl-4,4,4-trifluoro-1-butanesulfonate (BAY 59-3074): a novel cannabinoid Cb1/Cb2 receptor partial agonist with antihyperalgesic and antiallodynic effects. J Pharmacol Exp Ther. 2004 Aug;310(2):620-32. doi: 10.1124/jpet.103.062836. Epub 2004 May 12.
Background: PubMed 17296917Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
Background: PubMed 20805210Ware MA, Wang T, Shapiro S, Robinson A, Ducruet T, Huynh T, Gamsa A, Bennett GJ, Collet JP. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):E694-701. doi: 10.1503/cmaj.091414. Epub 2010 Aug 30.
Individual participant dataSharing planned: No

Related trials for Diabetic Neuropathies

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

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.

Debra Kimless, M.D. principal investigator

Pure Green, LLC

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CBD in people with Diabetic Neuropathies, run by Pure Green at 1 site in United States.

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 7 inclusion and 11 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 11 Dec 2019. 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score. (time frame: Three Weeks). 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 NCT04088929, which also lists 16 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 11 Dec 2019.