Study of CBME in the Relief of Painful Diabetic Neuropathy

June 10, 2022 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Randomised Control Trial Studying the Addition of CBME to Conventional Treatment for the Relief of Painful Diabetic Neuropathy

The study is designed to investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.

Hypothesis:

  1. The addition of CBME to the existing treatment regime will result in a significant improvement in both primary and secondary outcome measures.
  2. The side effect profile and tolerability of CBME will be minimal and comparable to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. To investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
  2. To study the tolerability and side effect profile of CBME.
  3. To study the effects of CBME treatment on vibration perception thresholds (VPT) and nerve conduction study parameters.
  4. To evaluate the effects of CBME on central nervous system deep nuclei using MR Spectroscopy.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diagnoses of diabetes will be based on the criteria set by the World Health Organisation.

Subjects must be over 18 years of age. Female subjects of child bearing potential and male subjects whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.

Written consent will be obtained. Volunteers must have had symptoms consistent with painful neuropathy for at least six months to be eligible for recruitment (NTSS 6 score of greater than 4 and less than 16).

Subjects in whom the symptoms of painful neuropathy persist despite an adequate trial with tricyclic antidepressants (TCA).

Stable dose of current treatment for neuropathy for at least 3 months prior to entry into the study.

Able (in the investigators opinion) and willing to comply with all study requirements.

Willing to allow his or her GP and consultant, if appropriate, to be notified of participation in the study.

Willing to allow his or her name to be notified to the Home Office and GW Pharma for participation in this study.

Exclusion Criteria:

Previous cerebrovascular events or other neurological disorders. unstable glycaemic control for six months. History of cardiovascular disorders. History of schizophrenia or any other psychiatric illnesses other than depression associated with painful diabetic neuropathy History of epilepsy. Serious illnesses precluding the gathering of or potentially having an impact on primary and secondary outcome measures for example major organ failure, neoplasia or coeliac disease.

Unwilling to stop driving or operating dangerous machinery for four hours after dosing on study medication or if experiencing its side effects.

Anticipated foreign travel within the first 15 weeks of the trial. Participants in other research studies currently or within the previous three months.

Current or past history of substance abuse. Previous or current history of consuming more than 20 units of alcohol a week. Neuropathy due to other aetiologies. Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.

Known or suspected adverse reaction to cannabinoids. Pregnancy or lactating mothers or planning pregnancy during the course of the study.

Not using adequate contraception Current use of fentanyl Significant renal or hepatic impairment as shown in medical history or indicated by clinical laboratory results from samples taken at baseline.

Scheduled elective surgery or other procedures requiring general anaesthesia during the study.

Regular levodopa therapy within 7 days of study entry. Severe cognitive impairment such that the patient is unable to provide informed consent.

Donation of blood during the study Other problems likely to make participation difficult at the discretion of the Treatment Physician

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement in pain symptoms, including pain perception and sleep quality, utilising daily diaries and validated pain questionnaires during 12 week treatment period and after 3 month cessation of treatment

Secondary Outcome Measures

Outcome Measure
1.Quality of life utilising validated questionnaires
questionnaires.
2.Evaluation of the tolerability and side effect profile of the study medication will be employed.
3. Neurophysiology including assessment of sensory and motor nerve function to the lower limbs.
(1, 2 & 3: During the 12 week treatment period and after 3 month cessation of treatment)
4. Magnetic Resonance Imaging
MR spectroscopy of the chemical constituents in the deep nuclei of the brain will be analysed before and after 12 week treatment period.

Collaborators and Investigators

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

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Diabetes UK

Investigators

  • Principal Investigator: Solomon Tesfaye, Sheffield Teaching Hosiptals NHS Foundation Trust

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

October 1, 2003

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 13, 2005

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH9042 02/343
  • BDA:RD03/0002590

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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