Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

NCT04679545 | Unknown Phase 2 DMC

• 1 other identifier: PG-DPN-20WS-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate whether PG-DN-20WS is a better pain reliever in patients with diabetic neuropathic pain of the feet than a placebo.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Cannabidiol; CBD; DPN; Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related adverse events as assessed by CTCAE v4.0

  To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control assessed by Common Terminology Criteria For Adverse Events (CTCAE) v4.0.

  Four Weeks

Secondary Outcomes (4)

• Pain as assessed by Numerical Pain Rating Scale (NPRS)

  Four Weeks

• Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS)

  Four Weeks

• Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI)

  Four Weeks

• Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)

  Four Weeks

Study Arms (2)

CBD

EXPERIMENTAL

Subject will receive a 28-day supply of 20 mg CBD sublingual tablets to be taken 3 times a day for 28 days.

Drug: CBD

Placebo Control

PLACEBO COMPARATOR

A placebo sublingual tablet to be taken three times a day for 28 days.

Drug: Placebo

Interventions

CBD DRUG

A water-soluble sublingual tablet containing 20 mg of CBD.

CBD

Placebo DRUG

An inactive compound.

Placebo Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 21 years of age;
• Subject has a diagnosis of diabetic neuropathic pain of the feet determined by the subject's primary care physician or related health care provider.
• Subject has a mean pain scale score of ≥ 5 recorded in the 7 days prior to randomization.
• If female, the subject is postmenopausal (\> 1 year), surgically sterile (\> 3 months), had a hysterectomy, or is currently using 2 effective forms of birth control.
• Subject has not taken 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 14 days prior to this study, and agrees 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.
• If subject is currently taking gabapentin, pregabalin, or duloxetine, subject must be willing to and completes a 7-day washout of these medications prior to randomization.
• Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to randomization.
• Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
• Subject is willing to use an electronic diary to enter trial information for 29 days.

You may not qualify if:

• Subject is pregnant or lactating;
• Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes;
• Subject has a known allergy to active or inert ingredients of the investigational product;
• 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 14 days prior to this study, and does not promise that they will 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;
• Subject currently resides in the state of Nebraska, Idaho, Iowa, or South Dakota.
• 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 has unstable angina, uncontrolled hypertension;
• Subject currently or has a history of congestive heart failure;
• Subject has any other unstable medical condition;
• Subject has a personal or family history of schizophrenia;
• Subject has a personal history or currently has suicidal ideation or attempted suicide;

Sponsors & Collaborators

• Pure Green: lead

Study Sites (1)

Pure Green Pharmaceuticals

Bloomfield Township, Michigan, 48323, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 12577252 BACKGROUND

• 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.

  PMID: 22608666 BACKGROUND

• 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.

  PMID: 16608048 BACKGROUND

• 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.

  PMID: 25498300 BACKGROUND

• 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.

  PMID: 12766111 BACKGROUND

• 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.

  PMID: 24373831 BACKGROUND

• Boulton AJ: Management of Diabetic Peripheral Neuropathy. Clinical Diabetes. 2005;23(1):9-15.

  BACKGROUND

• 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.

  PMID: 25843054 BACKGROUND

• 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.

  PMID: 11399676 BACKGROUND

• 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.

  PMID: 15140913 BACKGROUND

• 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.

  PMID: 17296917 BACKGROUND

• 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.

  PMID: 20805210 BACKGROUND

• 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.

  PMID: 23237736 BACKGROUND

• 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.

  PMID: 18403272 BACKGROUND

• 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.

  PMID: 19896326 BACKGROUND

• De Gregorio D, McLaughlin RJ, Posa L, Ochoa-Sanchez R, Enns J, Lopez-Canul M, Aboud M, Maione S, Comai S, Gobbi G. Cannabidiol modulates serotonergic transmission and reverses both allodynia and anxiety-like behavior in a model of neuropathic pain. Pain. 2019 Jan;160(1):136-150. doi: 10.1097/j.pain.0000000000001386.

  PMID: 30157131 BACKGROUND

Study Officials

• Debra Kimless, M.D.

  Pure Green Pharmaceuticals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Caloura

CONTACT

(248) 802-4380; mcaloura@pgpharma.co

Debra Kimless, M.D.

CONTACT

(248) 920-8761; dkimlessmd@pgpharma.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be randomized at a 1:1 ratio.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are 2 groups in this trial: interventional group (active drug) and control group (placebo).

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 22, 2020
• Study Start: December 10, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)