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Using Cannabidiol to Treat Diabetic Peripheral Neuropathy of the Feet

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ClinicalTrials.gov Identifier: NCT04679545
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Pure Green

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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathic Pain Drug: CBD Drug: Placebo Phase 2

Detailed Description:

Subjects will be enrolled in the study for a maximum of 43 days, including an optional 14-day screening period, 28 days of active product administration, and followed by a post-treatment follow-up within 1 day.

The primary objective of this study is:

  • To evaluate the safety of PG-DN-20WS for the treatment of painful DPN of the feet compared to a placebo control, including emergence of suicidal thoughts.

The secondary objectives of this study are:

  • To evaluate the impact of PG-DN-20WS on subject's neuropathic pain, anxiety, and sleep quality compared to a placebo control.
  • To evaluate the impact of PG-DN-20WS on the subject's impression of their response to the treatment compared to a placebo control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are 2 groups in this trial: interventional group (active drug) and control group (placebo).
Masking: Double (Participant, Investigator)
Masking Description: Subjects will be randomized at a 1:1 ratio.
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: CBD
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
A water-soluble sublingual tablet containing 20 mg of CBD.

Placebo Comparator: Placebo Control
A placebo sublingual tablet to be taken three times a day for 28 days.
Drug: Placebo
An inactive compound.




Primary Outcome Measures :
  1. Incidence of treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Four Weeks ]
    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.


Secondary Outcome Measures :
  1. Pain as assessed by Numerical Pain Rating Scale (NPRS) [ Time Frame: Four Weeks ]
    To evaluate the impact of PG-DN-20WS 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.

  2. Anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS) [ Time Frame: Four Weeks ]
    To evaluate the impact of PG-DN-20WS on the subject's anxiety as assessed by the Zung Self-Rating Anxiety Scale (SAS). Subjects are given scores from 1-4 based on their responses to the survey, where a higher global score indicates a more severe form of anxiety and a lower global score indicates either a less severe form of anxiety or no anxiety presented by the subject.

  3. Sleep Quality as assessed by Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Four Weeks ]
    To evaluate the impact of PG-DN-20WS on the subject's anxiety as assessed by the Pittsburgh Sleep Quality Index (PSQI). Subjects are given scores from 0-3 based on their responses to the survey, where a higher global score indicates poor sleep quality and a lower global score indicates good sleep quality reported by the subject.

  4. Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC) [ Time Frame: Four Weeks ]
    To evaluate the impact of PG-DN-20WS 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is at least 21 years of age;
  2. Subject has a diagnosis of diabetic neuropathic pain of the feet determined by the subject's primary care physician or related health care provider.
  3. Subject has a mean pain scale score of ≥ 5 recorded in the 7 days prior to randomization.
  4. 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.
  5. 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.
  6. 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.
  7. Subject has not taken any NSAIDs and/or acetaminophen for at least 2 days prior to randomization.
  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 is willing to use an electronic diary to enter trial information for 29 days.

Exclusion Criteria:

  1. Subject is pregnant or lactating;
  2. Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops), palmitoylethanolamide, or terpenes;
  3. Subject has a known allergy to active or inert ingredients of the investigational product;
  4. 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));
  5. 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;
  6. Subject currently resides in the state of Nebraska, Idaho, Iowa, or South Dakota.
  7. Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
  8. Subject has shortness of breath associated with allergies;
  9. Subject has uncontrolled asthma;
  10. Subject has a fever and/or productive cough;
  11. Subject has unstable angina, uncontrolled hypertension;
  12. Subject currently or has a history of congestive heart failure;
  13. Subject has any other unstable medical condition;
  14. Subject has a personal or family history of schizophrenia;
  15. Subject has a personal history or currently has suicidal ideation or attempted suicide;
  16. Subject has a major neurological disorder, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures.
  17. Subject has taken pharmaceutical pain medicine of any kind, or has taken a NSAID and/or acetaminophen, within 2 days of randomization.
  18. Subject has taken gabapentin, pregabalin, or duloxetine within 7 days prior to randomization or is unwilling to stop these medications.
  19. Subject has an allergy to, or has an intolerance to, NSAIDs or acetaminophen.
  20. Subject is currently taking any form of opioids.
  21. Subject has a history of substance or alcohol abuse.
  22. Subject has clinically significant illness, including cardiovascular disorders.
  23. 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.
  24. Subject does not have access to a smart phone or does not know how to use a smart phone application.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679545


Contacts
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Contact: Matthew Caloura (248) 802-4380 mcaloura@pgpharma.co
Contact: Debra Kimless, M.D. (248) 920-8761 dkimlessmd@pgpharma.co

Locations
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United States, Michigan
Pure Green Pharmaceuticals Recruiting
Bloomfield Township, Michigan, United States, 48323
Contact: Matthew Caloura    248-802-4380    mcaloura@pgpharma.co   
Contact: Debra Kimless, M.D.    (248) 920-8761    dkimlessmd@pgpharma.co   
Principal Investigator: Debra Kimless, M.D.         
Sponsors and Collaborators
Pure Green
Investigators
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Principal Investigator: Debra Kimless, M.D. Pure Green Pharmaceuticals
Publications:
Boulton AJ: Management of Diabetic Peripheral Neuropathy. Clinical Diabetes. 2005;23(1):9-15.

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Responsible Party: Pure Green
ClinicalTrials.gov Identifier: NCT04679545    
Other Study ID Numbers: PG-DPN-20WS-2020
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pure Green:
Cannabidiol
CBD
DPN
Diabetic Peripheral Neuropathy
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations