Study of CBME in the Relief of Painful Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00238550|
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : July 20, 2011
The study is designed to investigate the benefit of adding CBME to the existing treatment regime in the management of painful neuropathy.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy Painful||Drug: Cannabis based medicine extract (CBME)||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomised Control Trial Studying the Addition of CBME to Conventional Treatment for the Relief of Painful Diabetic Neuropathy|
|Study Start Date :||October 2003|
|Estimated Study Completion Date :||March 2006|
- 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
- 1.Quality of life utilising validated 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238550
|Royal Hallamshire Hospital|
|Sheffield, South Yorkshire, United Kingdom, S10 2JF|
|Principal Investigator:||Solomon Tesfaye||Sheffield Teaching Hosiptals NHS Foundation Trust|