Diabetic Peripheral Neuropahty MedDRA version: 8.1 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy
Conditions
Interventions
Trade Name: Lyrica
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREGABALIN
CAS Number: 148553508
Other descriptive name: Lyrica
Concentration unit: mg/g milligram(s)/gram
Concentration type
Sponsors
University of Surrey Clinical Research Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or above 2. Have a diagnosis of Diabetes mellitus for at least a year 3. Agree not to smoke whilst resident in the Clinical Research Centre 4. Able to understand the patient information sheet and provide written informed consent 5. Score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs 6. Have neuropathic pain of diabetic origin 7. Score above 25 on Mini Mental State Exam 8. Willing to withdraw, under the guidance of their diabetologist, from any current pain medication prior to their first visit to the sleep laboratory. Duration of withdrawal will be at least equivalent to 5 half-lives and will be of a relevant duration given the particular medication used. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. There is evidence of an end stage disease of a major system (hepatic, renal, respiratory, haematologic (PA), immunologic, cardiovascular, inflammatory, rheumatology, active infections, peripheral vascular disease, untreated endocrine(hypothyroid) 2. There is evidence of a recent ischaemic event 3. There is evidence of recurrent and/or severe hypoglycemia requiring assistance in last 3 years 4. Evidence of sleep pathology that would interfere with the assessment of treatment (assessed on habituation night) 5. Currently receiving treatment for malignancy 6. Suffer from seizures including epilepsy 7. There is evidence of a history of dependence on or abuse of alcohol/recreational drugs 8. Need to use a wheel chair (incompatible with studies in a sleep laboratory) 9. Involved in a clinical trial in last 3 months 10. Pregnant, lactating or inadequate contraception 11. Vision inadequate for the performance tests (as assessed at screening) 12. Colour Blind 13. Will not co-operate with study procedures 14. Will not give permission to inform GP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness of pregabalin, duloxetine and amitriptyline compared with placebo in reducing subjective pain associated with diabetic peripheral neuropathy (DPN) as assessed by the Brief Pain Inventory (BPI).;Secondary Objective: To investigate the effects of pregabalin, duloxetine and amitriptyline, at therapeutically relevant doses, on aspects of objective (polysomnography, PSG) and subjective sleep, morning after cognitive and psychomotor performance, and quality of life (QoL).;Primary end point(s): Whether there is a reduction in subjective pain as assessed by the Brief Pain Inventory. | — |
Countries
United Kingdom
Outcome results
None listed