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

March 2, 2023 updated by: Pure Green Pharmaceuticals Inc.

A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is at least 21 years of age.
  2. Subject is or under the age of 65 years of age.
  3. Subject has a primary health care provider and gives permission for PG Pharma to contact the primary health care provider.
  4. Subject has a diagnosis of diabetic neuropathic pain of the feet .
  5. Subject has a mean pain scale score of ≥ 4 and ≤ 8 recorded localized to the foot in the 7 days prior to randomization.
  6. 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.
  7. 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.
  8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
  9. 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:

  1. Subject is pregnant or lactating.
  2. Subject is unwilling to utilize two forms of birth control with partner.
  3. Male subject is unwilling to agree to not donate sperm from the time of dosing until 90 days after dosing of study drug.
  4. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes.
  5. Subject has a known allergy to active or inert ingredients of the investigational product.
  6. 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.
  7. Subjects on SNRIs or SSRIs.
  8. 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;
  9. Subject has shortness of breath.
  10. Subject has uncontrolled asthma.
  11. Subject has a fever and/or productive cough.
  12. Subject has unstable angina, uncontrolled hypertension.
  13. Subject currently or has a history of congestive heart failure.
  14. 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.
  15. Subject has a personal or family history of schizophrenia.
  16. Subject has a personal history or currently has suicidal ideation or attempted suicide.
  17. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures.
  18. Subject has a history of multiple sclerosis.
  19. Subject is currently taking any form of opioids.
  20. Subject has a history of substance or alcohol abuse.
  21. Subject has clinically significant illness, including cardiovascular disorders.
  22. 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.
  23. Subject does not have access to a smart phone or does not know how to use a smart phone application.
  24. Subject is not within 30 miles of a Quest Diagnostics laboratory.
  25. The skin under the tongue or anywhere in the oral cavity is not intact.
  26. Subject has abnormal liver function test results.
  27. Subject has a history of abnormal liver dysfunction or liver pathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBD/PEA
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
A water-soluble sublingual tablet containing 10/50 mg of CBD/PEA.
Other Names:
  • PGP-DPN-10/50
Placebo Comparator: Placebo Control
A placebo sublingual tablet to be taken three times a day for 42 days.
Drug: Placebo
An inactive compound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Time Frame: Six Weeks
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)
Time Frame: Six Weeks
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)
Time Frame: Six Weeks
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)
Time Frame: Six Weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Six Weeks
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.
Six Weeks
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
Time Frame: Six Weeks
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.
Six Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pure Green Pharmaceuticals Inc.

Investigators

  • Principal Investigator: Debra Kimless, MD, Pure Green Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 5, 2023

Primary Completion (Anticipated)

December 5, 2023

Study Completion (Anticipated)

December 5, 2023

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The DIA/NPR-6 Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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