Study of CBME in the Relief of Painful Diabetic Neuropathy

NCT ID: NCT00238550

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2006-03-31

Brief Summary

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.

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.

Conditions

Diabetic Neuropathy; Painful

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Cannabis based medicine extract (CBME)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diabetes UK

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Solomon Tesfaye

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hosiptals NHS Foundation Trust

Locations

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

BDA:RD03/0002590

Identifier Type: -

Identifier Source: secondary_id

STH9042 02/343

Identifier Type: -

Identifier Source: org_study_id