Diabetic NeuropathyPhase 2NCT00238550
Study of CBME in the Relief of Painful Diabetic Neuropathy
A Phase 2 study testing Cannabis based medicine extract (CBME) in people with Diabetic Neuropathy and Painful, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Cannabis based medicine extract (CBME)
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2003to Mar 2006
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: 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:
- The addition of CBME to the existing treatment regime will result in a significant improvement in both primary and secondary outcome measures.
- The side effect profile and tolerability of CBME will be minimal and comparable to placebo.
Read the detailed description
- To investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
- To study the tolerability and side effect profile of CBME.
- To study the effects of CBME treatment on vibration perception thresholds (VPT) and nerve conduction study parameters.
- To evaluate the effects of CBME on central nervous system deep nuclei using MR Spectroscopy.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Cannabis based medicine extract (CBME)
- Keywords
- Diabetes, Pain, Peripheral neuropathy
- Medical subject headings
- Diabetic Neuropathies, Pain, Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis based medicine extract (CBME)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (7)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startOct 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes UK
- Investigators
- Solomon Tesfaye, Principal investigator, Sheffield Teaching Hosiptals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238550
- Sponsor's protocol ID
- STH9042 02/343
- Other IDs
- BDA:RD03/0002590
- Status last verified
- Jun 2022
- First submitted
- 12 Oct 2005
- Last updated
- 13 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial Studying the Addition of CBME to Conventional Treatment for the Relief of Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00238550
- Acronym / sponsor ID
- STH9042 02/343
- Conditions
- Diabetic Neuropathy, Painful
- Keywords
- Diabetes, Pain, Peripheral neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Diabetes UK
- Study start
- Oct 2003
- Study completion
- Mar 2006
- First posted
- 13 Oct 2005 (estimated)
- 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 study is designed to investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
Hypothesis:
- The addition of CBME to the existing treatment regime will result in a significant improvement in both primary and secondary outcome measures.
- The side effect profile and tolerability of CBME will be minimal and comparable to placebo.
Detailed description
- To investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
- To study the tolerability and side effect profile of CBME.
- To study the effects of CBME treatment on vibration perception thresholds (VPT) and nerve conduction study parameters.
- To evaluate the effects of CBME on central nervous system deep nuclei using MR Spectroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Cannabis based medicine extract (CBME) | Drug | – |
Primary outcome
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
7 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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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.
Solomon Tesfaye principal investigator
Sheffield Teaching Hosiptals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis based medicine extract (CBME) in people with Diabetic Neuropathy and Painful, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 13 Jun 2022. 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 Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2022.