Diabetic Peripheral Neuropathic PainPhase 1/2NCT05766969
Diabetic Neuropathic Pain Relief, 6 Weeks Dosage Sublingual Water-soluble CBD/PEA
A Phase 1/2 study testing CBD/PEA in people with Diabetic Peripheral Neuropathic Pain, run by Pure Green Pharmaceuticals Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- CBD/PEA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 5 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pure Green Pharmaceuticals Inc.
Southfield, Michigan, 48034
Debra Kimless, MD, 248-920-8761, dkimlessmd@pgpharma.co
Donna McLean, 248-800-6126, dmclean@pgpharma.co
About this study
Official title: 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.
Read the 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
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- CBD/PEA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD/PEADrug
Also called PGP-DPN-10/50
A water-soluble sublingual tablet containing 10/50 mg of CBD/PEA.
PlaceboDrug
An inactive compound.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CBD/PEA |
| Placebo Control | Placebo comparator | A placebo sublingual tablet to be taken three times a day for 42 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six Weeks
Secondary outcomes (2)
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.
Measured: Six Weeks
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.
Measured: Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start5 Jun 2023 (estimated)
- Primary completion5 Dec 2023 (estimated)
- Study completion5 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups in this trial: interventional group (active drug) and control group (placebo).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pure Green Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra Kimless, MD, Principal investigator, Pure Green Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766969
- Sponsor's protocol ID
- The DIA/NPR-6 Study
- Status last verified
- May 2022
- First submitted
- 2 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12577252Callaghan 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.
PubMed 22608666Argoff 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.
PubMed 16608048Sadosky 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.
PubMed 25498300Gordois 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.
PubMed 12766111Singh 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.
PubMed 24373831Wallace 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.
PubMed 25843054Bridges D, Ahmad K, Rice AS. The synthetic cannabinoid WIN55,212-2 attenuates hyperalgesia and allodynia in a rat model of neuropathic pain. Br J Pharmacol. 2001 Jun;133(4):586-94. doi: 10.1038/sj.bjp.0704110.
PubMed 11399676De Vry J, Denzer D, Reissmueller E, Eijckenboom M, Heil M, Meier H, Mauler F. 3-[2-cyano-3-(trifluoromethyl)phenoxy]phenyl-4,4,4-trifluoro-1-butanesulfonate (BAY 59-3074): a novel cannabinoid Cb1/Cb2 receptor partial agonist with antihyperalgesic and antiallodynic effects. J Pharmacol Exp Ther. 2004 Aug;310(2):620-32. doi: 10.1124/jpet.103.062836. Epub 2004 May 12.
PubMed 15140913Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
PubMed 17296917Ware 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.
PubMed 20805210Wilsey 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.
PubMed 23237736Wilsey 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.
PubMed 18403272Johnson 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.
PubMed 19896326De 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.
PubMed 30157131
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet
- ClinicalTrials.gov ID
- NCT05766969
- Acronym / sponsor ID
- The DIA/NPR-6 Study
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Pure Green Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (estimated)
- Primary completion
- 5 Dec 2023 (estimated)
- Study completion
- 5 Dec 2023 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- There are 2 groups in this trial: interventional group (active drug) and control group (placebo).
| Arm | Type | Receives |
|---|---|---|
| CBD/PEA | Experimental | Drug: CBD/PEASubject will receive a 42-day supply of 10/50 mg CBD/PEA sublingual tablets to be taken 3 times a day for 42 days. |
| Placebo Control | Placebo comparator | Drug: PlaceboA placebo sublingual tablet to be taken three times a day for 42 days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD/PEAAlso: PGP-DPN-10/50A water-soluble sublingual tablet containing 10/50 mg of CBD/PEA. | Drug | CBD/PEA |
| PlaceboAn inactive compound. | Drug | Placebo Control |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Six Weeks
Subject's Response to Treatment as assessed by Patient's Global Impression of Change (PGIC)
Time frame: Six Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Background: PubMed 12577252Quattrini 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.
- Background: PubMed 22608666Callaghan 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.
- Background: PubMed 16608048Argoff 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.
- Background: PubMed 25498300Sadosky 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.
- Background: PubMed 12766111Gordois 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.
- Background: PubMed 24373831Singh 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.
- Background: PubMed 25843054Wallace 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.
- Background: PubMed 11399676Bridges D, Ahmad K, Rice AS. The synthetic cannabinoid WIN55,212-2 attenuates hyperalgesia and allodynia in a rat model of neuropathic pain. Br J Pharmacol. 2001 Jun;133(4):586-94. doi: 10.1038/sj.bjp.0704110.
- Background: PubMed 15140913De Vry J, Denzer D, Reissmueller E, Eijckenboom M, Heil M, Meier H, Mauler F. 3-[2-cyano-3-(trifluoromethyl)phenoxy]phenyl-4,4,4-trifluoro-1-butanesulfonate (BAY 59-3074): a novel cannabinoid Cb1/Cb2 receptor partial agonist with antihyperalgesic and antiallodynic effects. J Pharmacol Exp Ther. 2004 Aug;310(2):620-32. doi: 10.1124/jpet.103.062836. Epub 2004 May 12.
- Background: PubMed 17296917Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
- Background: PubMed 20805210Ware 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.
- Background: PubMed 23237736Wilsey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra Kimless, MD principal investigator
Pure Green Pharmaceuticals Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBD/PEA in people with Diabetic Peripheral Neuropathic Pain, run by Pure Green Pharmaceuticals Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debra Kimless, MD (248-920-8761, dkimlessmd@pgpharma.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as assessed by Numerical Pain Rating Scale (NPRS) (time frame: Six Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766969, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.