Trial · NCT02878798
Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
NCT02878798, Phase 2, Completed, Virginia Commonwealth University; results first posted 2023-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN). Trials, record NCT02878798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02878798
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
- NCT number
- NCT02878798
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 132 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome
- Interventions
- topiramate, Placebo
- First posted
- 2016-08-25
- Last updated
- 2023-11-14
- Results first posted
- 2023-11-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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). |
| Primary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraepidermal Nerve Fiber Density (IENFD) | 96 weeks | fibers/mm/year (52 weeks) | LEAST_SQUARES_MEAN | |
| PRIMARY | Norfolk Quality of Life - Diabetic Neuropathy | 96 weeks (expressed as a slope in change of total score/52 weeks) | Change inTotal NQOL-DN score over 52 wks | LEAST_SQUARES_MEAN | |
| SECONDARY | Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference | 96 weeks (expressed as a change in change in pain interference/52weeks) | Slope of change in BPI-DN PI over 52 wks | LEAST_SQUARES_MEAN | |
| SECONDARY | Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity | 96 weeks (expressed as a slope of change over 52 weeks) | Slope of change in BPI-DN pain over 52 w | LEAST_SQUARES_MEAN | |
| SECONDARY | Utah Early Neuropathy Scale | 96 weeks (expressed as a slope of change in total UENS over 52 weeks). | Slope of change in Total UENS over 52wks | LEAST_SQUARES_MEAN | |
| SECONDARY | Sural Sensory Amplitude (SSA) | 96 weeks (slope of change in mV/52weeks) | slope of change in SSA uV over 52 wks | LEAST_SQUARES_MEAN | |
| SECONDARY | Peroneal Motor Conduction Velocity (PMCV) | 96 weeks (expressed as a slope of change in meter/sec over 52 weeks) | Slope of change in M/S over 52 wks | LEAST_SQUARES_MEAN | |
| SECONDARY | Body Mass Index (BMI) | 96 weeks (slope of change in kg/m2/52 weeks) | Slope of change in BMI kg/m2 over 52wks | LEAST_SQUARES_MEAN | |
| SECONDARY | Hemoglobin A1C | The annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weeks | change in %/52 weeks over 96 weeks | LEAST_SQUARES_MEAN | |
| SECONDARY | Serum Triglycerides (TRG) | 96 weeks (slope of change mg/dl over 52 weeks) | change in mg/dl/52 weeks over 96 weeks | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraepidermal Nerve Fiber Density (IENFD) | Placebo | -0.6064 | 95% Confidence Interval -1.1785 to -0.03437 | fibers/mm/year (52 weeks) | |
| Intraepidermal Nerve Fiber Density (IENFD) | Topiramate | -0.396 | 95% Confidence Interval -0.9625 to 0.1705 | fibers/mm/year (52 weeks) | |
| Norfolk Quality of Life - Diabetic Neuropathy | Placebo | 3.5815 | 95% Confidence Interval 1.3162 to 5.8467 | Change inTotal NQOL-DN score over 52 wks | |
| Norfolk Quality of Life - Diabetic Neuropathy | Topiramate | 2.0596 | 95% Confidence Interval -0.2545 to 4.3737 | Change inTotal NQOL-DN score over 52 wks | |
| Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference | Placebo | 0.1999 | 95% Confidence Interval -0.3602 to 0.7600 | Slope of change in BPI-DN PI over 52 wks | |
| Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference | Topiramate | 0.1767 | 95% Confidence Interval -0.3984 to 0.7517 | Slope of change in BPI-DN PI over 52 wks | |
| Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity | Placebo | -0.1046 | 95% Confidence Interval -0.3431 to 0.1338 | Slope of change in BPI-DN pain over 52 w | |
| Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity | Topiramate | -0.2726 | 95% Confidence Interval -0.5176 to -0.0276 | Slope of change in BPI-DN pain over 52 w | |
| Utah Early Neuropathy Scale | Placebo | 0.4281 | 95% Confidence Interval -0.2409 to 1.0970 | Slope of change in Total UENS over 52wks | |
| Utah Early Neuropathy Scale | Topiramate | 0.3671 | 95% Confidence Interval -0.3220 to 1.0562 | Slope of change in Total UENS over 52wks |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 66 | |
| Overall Study | STARTED | Topiramate | 66 | |
| Overall Study | COMPLETED | Placebo | 59 | |
| Overall Study | COMPLETED | Topiramate | 59 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Topiramate | 7 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Placebo | 7 | 66 | |
| other | Diarrhea | Gastrointestinal disorders | Topiramate | 10 | 66 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 4 | 66 | |
| other | Dry Mouth | Gastrointestinal disorders | Topiramate | 4 | 66 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 66 | |
| other | Nausea | Gastrointestinal disorders | Topiramate | 6 | 66 | |
| other | Fatigue | General disorders | Placebo | 5 | 66 | |
| other | Fatigue | General disorders | Topiramate | 13 | 66 | |
| other | Sinusitis | Infections and infestations | Placebo | 4 | 66 | |
| other | Sinusitis | Infections and infestations | Topiramate | 5 | 66 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 66 |
| Total, all-cause mortality | Topiramate | 0 | 66 |
| Total, other adverse events | Placebo | 56 | 66 |
| Total, other adverse events | Topiramate | 61 | 66 |
| Total, serious adverse events | Placebo | 9 | 66 |
| Total, serious adverse events | Topiramate | 4 | 66 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37870862 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS095388 | Topiramate as a Disease Altering Therapy for CSPN | SMITH, A. GORDON; COFFEY, CHRISTOPHER S.; CUDKOWICZ, MERIT E; SINGLETON, JOHN ROBINSON | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2017 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topiramate vs Placebo: deaths from any cause | Trial comparisons |
| Topiramate vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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