Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
- Conditions
- Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome
- Interventions
- Other: Placebo
- Registration Number
- NCT02878798
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo An overencapsulated placebo of identical color, shape and packaging to topiramate will be used. Topiramate topiramate Oral topiramate
- Primary Outcome Measures
Name Time Method Norfolk Quality of Life - Diabetic Neuropathy 96 weeks (expressed as a slope in change of total score/52 weeks) Difference in NQOL between treatment groups over 96 weeks. The Norfolk QOL-DN is a validated 47-item, patient-reported outcome measure, sensitive to the different features of diabetic neuropathy (DN) including small fiber, large fiber, and autonomic function. A lower score is better. The range of the score is from -4 to 136. The slope of the change in total Norfolk QOL-DD is calculated as the change in total score/52 weeks (one year)
Intraepidermal Nerve Fiber Density (IENFD) 96 weeks Difference in IENFD change between treatment groups over 96 weeks (fibers/mm) (i.e. the slope of change). A skin biopsy is obtained. The sample is stained for nerve fibers. The rate of change in IENFD in fibers/mm is calculated over the 96 week duration of the study and expressed in change in fibers/mm/year (defined as 52 weeks) over the study period (i.e. the slope of change expressed and change in IENFD in fibers/mm over a 52 week period).
- Secondary Outcome Measures
Name Time Method Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference 96 weeks (expressed as a change in change in pain interference/52weeks) Pain interference score. Each item is scored from 0-10 with a total possible number of points of 70, higher worse. The range of the score is 0-70. The change in score is expressed as a slope of change in pain interference score/52 weeks (one year)
Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity 96 weeks (expressed as a slope of change over 52 weeks) Average pain severity. Each item is scored 0-10 with a total of 40 possible points, higher is worse. The range of the score is 0-40. The slope of the change in this score is expressed as change/one year (defined as 52 weeks)
Utah Early Neuropathy Scale 96 weeks (expressed as a slope of change in total UENS over 52 weeks). The UENS is a validated examination score of neuropathy severity based on a physical examination (Singleton et al 2008). Total score is 42 (minimum 0 and maximum 42). The higher the score, the worse the outcome is. The change in UENS over the 96 week period is expressed as a slope of change in total UENS over one year defined as 52 weeks.
Sural Sensory Amplitude (SSA) 96 weeks (slope of change in mV/52weeks) Change in SSA measured in microvolts. SSA is measured by electrically stimulating a nerve through the skin and recording the response. A larger value is better. The normal values vary based on age, with a minimum of 0 (absent). Across all ages, the lower limit of normal is 6 microvolts, although the normal cutoff declines with aging. The change in SSA over the 96 week study period is expressed as a slope of change in uV/52 weeks (the 52 week log (mV) change of non-zero values).
Peroneal Motor Conduction Velocity (PMCV) 96 weeks (expressed as a slope of change in meter/sec over 52 weeks) PMCV change. PMCV is measured by electrically stimulating the nerve through the skin at two different locations and measuring how fast the response travels between the two in meters/second. A higher value is better. The slope of the change in PMCV is expressed as change in meters/second/52 weeks (one year).
Body Mass Index (BMI) 96 weeks (slope of change in kg/m2/52 weeks) BMI change in kg/m2. BMI is a measure of weight relative to height. The slope of the change in BMI over the study was expressed as change in kg/m2/52 weeks.
Hemoglobin A1C The annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weeks Slope of the Hemoglobin A1C change. A1C is measured in percent. It provides an estimate of how high blood sugar has been over the past three months. A higher value indicates poor diabetic control.
Serum Triglycerides (TRG) 96 weeks (slope of change mg/dl over 52 weeks) TRG change. TRG are a type of lipid or fat circulating in the blood. A higher value is associated with increased cardiovascular risk. The slope of the change in TRG was calculated as change in mg/dl over 52 weeks (one year).
LDL Cholesterol 96 weeks (expressed as a slope of change in mg/dl/52 weeks) LDL change. LDL is "bad" cholesterol, measured in mg/dL. A higher value is associated with elevated cardiovascular risk. A slope of change is calculated change in LDL in mg/dL/52 weeks (one year)
HDL Cholesterol 96 weeks (expressed as slope of change in mg/dL/52 weeks) HDL change. HDL is "good cholesterol", measured in mg/dL. A lower value is associated with higher cardiovascular risk. The slope of change is calculated as change in mg/dL/52 weeks (one year)
Trial Locations
- Locations (20)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Miami
🇺🇸Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Eastern Virginia Medical Center
🇺🇸Norfolk, Virginia, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
University of Michigan Neurology Clinical Trials Organization
🇺🇸Ann Arbor, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of California Irvine
🇺🇸Orange, California, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States