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

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBD/PEA
Placebo
Sponsored by
Pure Green Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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)). However, subjects are allowed to continue gabapentin and pregabalin medications, if the subject still meets the pain scale inclusion criteria, evidencing lack of effectiveness of their concomitant pain medication. 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. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures. Subject has a history of multiple sclerosis. Subject is currently taking any form of opioids. Subject has a history of substance or alcohol abuse. Subject has clinically significant illness, including cardiovascular disorders. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm. Subject does not have access to a smart phone or does not know how to use a smart phone application. Subject is not within 30 miles of a Quest Diagnostics laboratory. The skin under the tongue or anywhere in the oral cavity is not intact. Subject has abnormal liver function test results. Subject has a history of abnormal liver dysfunction or liver pathology.

Sites / Locations

  • Pure Green Pharmaceuticals Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBD/PEA

Placebo Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Incidence of treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety of DIA/NPR-6 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.
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
To evaluate the impact of DIA/NPR-6 on the subject's impression of their response to the treatment compared to a placebo control as assessed by Patient's Global Impression of Change (PGIC). Subjects indicate their overall impression of their response to treatment on 0-10 scale, where a higher number represents the subject feeling worse than before the intervention, and a lower number represents the subject feeling better than before the intervention.

Full Information

First Posted
March 2, 2023
Last Updated
March 2, 2023
Sponsor
Pure Green Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05766969
Brief Title
Diabetic Neuropathic Pain Relief, 6 Weeks Dosage Sublingual Water-soluble CBD/PEA
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 5, 2023 (Anticipated)
Primary Completion Date
December 5, 2023 (Anticipated)
Study Completion Date
December 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pure Green Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Subjects will be enrolled in the study for a maximum of 63 days, including an optional 14-day screening period, 42 days of active product administration, and followed by post-treatment blood work, EKG, and questionnaires within 24-hours following study treatment completion and a psychiatric and primary health care provider evaluation within 1 week of trial completion. The primary objective of this study is: To evaluate the impact of PGP-010-50-1 on subject's painful diabetic neuropathic pain (pDNP), anxiety, and sleep quality compared to a placebo control. To evaluate the impact of PGP-010-50-1 on the subject's impression of their response to the treatment compared to a placebo control. The secondary objectives of this study are: To evaluate the safety of PGP-010-50-1 for the treatment of painful diabetic peripheral neuropathy (DPN) of the feet compared to a placebo control To evaluate PGP-010-50-1 on liver function. To evaluate PGP-010-50-1 on Hbg A1C

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
There are 2 groups in this trial: interventional group (active drug) and control group (placebo).
Masking
ParticipantInvestigator
Masking Description
Subjects will be randomized at a 2:1 ratio.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBD/PEA
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
A placebo sublingual tablet to be taken three times a day for 42 days.
Intervention Type
Drug
Intervention Name(s)
CBD/PEA
Other Intervention Name(s)
PGP-DPN-10/50
Intervention Description
A water-soluble sublingual tablet containing 10/50 mg of CBD/PEA.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
An inactive compound.
Primary Outcome Measure Information:
Title
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
Six Weeks
Title
Pain as measured by the Brief Pain Inventory (BPI)
Description
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.
Time Frame
Six Weeks
Title
Anxiety as measured by the Self-Rating Anxiety Scale (SAS)
Description
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.
Time Frame
Six Weeks
Title
Sleep as measured by the Pittsburg Sleep Quality Index (PSQI)
Description
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.
Time Frame
Six Weeks
Secondary Outcome Measure Information:
Title
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Description
To evaluate the safety of DIA/NPR-6 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.
Time Frame
Six Weeks
Title
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
Description
To evaluate the impact of DIA/NPR-6 on the subject's impression of their response to the treatment compared to a placebo control as assessed by Patient's Global Impression of Change (PGIC). Subjects indicate their overall impression of their response to treatment on 0-10 scale, where a higher number represents the subject feeling worse than before the intervention, and a lower number represents the subject feeling better than before the intervention.
Time Frame
Six Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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)). However, subjects are allowed to continue gabapentin and pregabalin medications, if the subject still meets the pain scale inclusion criteria, evidencing lack of effectiveness of their concomitant pain medication. 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. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures. Subject has a history of multiple sclerosis. Subject is currently taking any form of opioids. Subject has a history of substance or alcohol abuse. Subject has clinically significant illness, including cardiovascular disorders. Subject has any condition in which the investigator believes will confound the data of the study or could put the subject at risk of harm. Subject does not have access to a smart phone or does not know how to use a smart phone application. Subject is not within 30 miles of a Quest Diagnostics laboratory. The skin under the tongue or anywhere in the oral cavity is not intact. Subject has abnormal liver function test results. Subject has a history of abnormal liver dysfunction or liver pathology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Kimless, MD
Phone
248-920-8761
Email
dkimlessmd@pgpharma.co
First Name & Middle Initial & Last Name or Official Title & Degree
Donna McLean
Phone
248-800-6126
Email
dmclean@pgpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, MD
Organizational Affiliation
Pure Green Pharmaceuticals Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pure Green Pharmaceuticals Inc.
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Kimless, MD
Phone
248-920-8761
Email
dkimlessmd@pgpharma.co
First Name & Middle Initial & Last Name & Degree
Donna McLean
Phone
248-800-6126
Email
dmclean@pgpharma.co

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12577252
Citation
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.
Results Reference
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22608666
Citation
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.
Results Reference
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16608048
Citation
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.
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25498300
Citation
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.
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Diabetic Neuropathic Pain Relief, 6 Weeks Dosage Sublingual Water-soluble CBD/PEA

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