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Cannabinoid
CBD/PEA for Diabetic Neuropathy
Phase 1 & 2
Waitlist Available
Led By Debra Kimless, MD
Research Sponsored by Pure Green Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks
Summary
This trial compares a drug (DIA/NPR-6) to a placebo to see if it relieves diabetic nerve pain in the feet.
Eligible Conditions
- Diabetic Neuropathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety as measured by the Self-Rating Anxiety Scale (SAS)
Pain as assessed by Numerical Pain Rating Scale (NPRS)
Pain as measured by the Brief Pain Inventory (BPI)
+1 moreSecondary study objectives
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBD/PEAExperimental Treatment1 Intervention
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.
Group II: Placebo ControlPlacebo Group1 Intervention
A placebo sublingual tablet to be taken three times a day for 42 days.
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Who is running the clinical trial?
Pure Green Pharmaceuticals Inc.Lead Sponsor
Debra Kimless, MDPrincipal InvestigatorPure Green Pharmaceuticals Inc.
1 Previous Clinical Trials
16 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to cannabis, hemp, hops, or certain other plant substances.You are taking a medication or using a treatment that could make it hard to understand how the study drug is working, like cannabis or other drugs that affect the endocannabinoid system. But, you can still take gabapentin and pregabalin if they aren't helping with your pain.You are taking SNRIs or SSRIs.You have asthma that is not well managed or controlled.You have a fever and/or cough with mucus.You have trouble breathing.You have had thoughts of harming yourself or have tried to harm yourself in the past.You have a significant neurological condition like dementia, Parkinson's disease, or epilepsy.You have been diagnosed with multiple sclerosis in the past.You are currently using any type of opioid medication.You have a history of using drugs or drinking too much alcohol.You have a serious illness, including heart problems.You have any open sores or wounds in your mouth.Your liver function test results are not normal.You currently have or have had heart failure.You have a serious mental illness like bipolar disorder, major depression, or substance abuse.You or someone in your family has a history of schizophrenia.You have had liver problems in the past.You are at least 21 years old.You are younger than 65 years old.You have been diagnosed with pain in your feet caused by diabetes.Your foot pain score has been between 4 and 8 in the past week.You have not used any form of marijuana or cannabis-related products for at least 14 days before the study, and you agree not to use them during the study.You have used marijuana in any form, including CBD, in the last 14 days or plan to use it during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Control
- Group 2: CBD/PEA
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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