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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 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. The trial reports 20 study locations across 18 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02878798
The ClinicalTrials.gov registry entry for NCT02878798 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.
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