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NCT02878798 · ClinicalTrials.gov registry record · Phase 2
Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
A Phase 2 study of Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT02878798: Completed Phase 2 study of Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome, sponsored by Virginia Commonwealth University.
NCT02878798 is a Phase 2 study of Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome that has completed, run by Virginia Commonwealth University. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02878798, a Phase 2 study of Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG topiramate
Study Locations (20)
New York
- Columbia University Medical Center - New York
- University of Rochester Medical Center - Rochester
Virginia
- Eastern Virginia Medical Center - Norfolk
- Virginia Commonwealth University - Richmond
Alabama
- University of Alabama Birmingham - Birmingham
Arizona
- Barrow Neurological Institute - Phoenix
California
- University of California Irvine - Orange
Florida
- University of Miami - Miami
Illinois
- Northwestern University - Chicago
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2021-09-28 |
| Phase | Phase 2 |
What the finished NCT02878798 record still lists
NCT02878798 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 1 condition, with Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02878798 names 20 study sites across 18 states, led by New York, Virginia, Alabama.
Frequently Asked Questions
What is clinical trial NCT02878798 about?
NCT02878798 is a clinical study titled "Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)". 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 alternat...
What is the current status of trial NCT02878798?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2018-02-12. Estimated completion is 2021-09-28.
What conditions does trial NCT02878798 study?
This clinical trial studies the following conditions: Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome.
What interventions are being tested in trial NCT02878798?
The interventions under investigation include: Placebo (OTHER), topiramate (DRUG).
Who is sponsoring clinical trial NCT02878798?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02878798 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02878798's enrollment target sits among peer trials
132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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