Diabetic Neuropathic Pain Relief, 6 Weeks Dosage Sublingual Water-soluble CBD/PEA

NCT05766969 | Unknown Phase 1 FDA Drug

• 1 other identifier: The DIA/NPR-6 Study
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate whether the DIA/NPR-6 is a better pain reliever in patients with diabetic neuropathic pain of the feet compared to placebo.

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (4)

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

  To evaluate the impact of DIA/NPR-6 on the subject's neuropathic pain as assessed by utilizing a Numeric Pain Rating Scale (NPRS). NPRS is from 0-10, where higher scores indicate worse pain, and lower scores indicate less pain reported by the subject.

  Six Weeks

• Pain as measured by the Brief Pain Inventory (BPI)

  To evaluate the impact of DIA/NPR-6 on the subject's neuropathic pain as assessed by utilizing a Brief Pain Inventory (BPI) where patients will answer 15 questions regarding their pain.

  Six Weeks

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

  To evaluate the impact of DIA/NPR-6 on the subject's anxiety as assessed by the Self-Rating Anxiety Scale (SAS). Subjects will complete SAS prior to first dose and during post-treatment.

  Six Weeks

• Sleep as measured by the Pittsburg Sleep Quality Index (PSQI)

  To evaluate the impact of DIA/NPR-6 on the subject's sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). Subjects will be evaluated pre- and post-treatment. The PSQI produces a global score and 6 subscales, Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbances, Use of Sleeping Medications, and Daytime Dysfunction.

  Six Weeks

Secondary Outcomes (2)

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

  Six Weeks

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

  Six Weeks

Study Arms (2)

CBD/PEA

EXPERIMENTAL

Subject will receive a 42-day supply of 10/50 mg CBD/PEA sublingual tablets to be taken 3 times a day for 42 days.

Drug: CBD/PEA

Placebo Control

PLACEBO COMPARATOR

A placebo sublingual tablet to be taken three times a day for 42 days.

Drug: Placebo

Interventions

CBD/PEA DRUG

A water-soluble sublingual tablet containing 10/50 mg of CBD/PEA.

Also known as: PGP-DPN-10/50

CBD/PEA

Placebo DRUG

An inactive compound.

Placebo Control

Eligibility Criteria

• Age: 21 Years - 65 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 is or under the age of 65 years of age.
• Subject has a primary health care provider and gives permission for PG Pharma to contact the primary health care provider.
• Subject has a diagnosis of diabetic neuropathic pain of the feet .
• Subject has a mean pain scale score of ≥ 4 and ≤ 8 recorded localized to the foot 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.
• Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
• Subject has a smart phone, knows how to use it, and is willing to use it for accessing and interacting with an electronic diary to enter trial information for the duration of the study - 57 days. (up to 14-day screening period and 42 days active dosing and 1 day post dosing.

You may not qualify if:

• Subject is pregnant or lactating.
• Subject is unwilling to utilize two forms of birth control with partner.
• Male subject is unwilling to agree to not donate sperm from the time of dosing until 90 days after dosing of study drug.
• 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.
• Subjects on SNRIs or SSRIs.
• 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 has shortness of breath.
• 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 meets any DSM-V criteria for current, major psychiatric illness, including but not limited to: bipolar disorder, major depressive disorder, psychosis, or substance abuse disorder.
• 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 Pharmaceuticals Inc.: lead

Study Sites (1)

Pure Green Pharmaceuticals Inc.

Southfield, Michigan, 48034, United States

Location

Related Publications (15)

• 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.

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• 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.

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• 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.

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• 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.

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• 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, MD

  Pure Green Pharmaceuticals Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debra Kimless, MD

CONTACT

248-920-8761; dkimlessmd@pgpharma.co

Donna McLean

CONTACT

248-800-6126; dmclean@pgpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects will be randomized at a 2:1 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: March 2, 2023
• First Posted: March 13, 2023
• Study Start: June 5, 2023
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: March 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)