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NCT02260388 · ClinicalTrials.gov registry record · Phase 4
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
A Phase 4 study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 402
- Enrollment target
NCT02260388: Completed Phase 4 study, sponsored by University of Kansas Medical Center.
NCT02260388 is a Phase 4 study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 402 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260388, a Phase 4 study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 402 participants
- Enrollment target
Study Summary
The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).
Primary Outcome
The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visi
Interventions
- DRUG Duloxetine
- DRUG Pregabalin
- DRUG Nortriptyline
- DRUG Mexiletine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-09 |
| Phase | Phase 4 |
What the finished NCT02260388 record still lists
NCT02260388 is an interventional study that assigns participants to a tested intervention. The registered 402 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 4 interventions - of which Duloxetine is the first listed.
NCT02260388 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02260388 about?
NCT02260388 is a clinical study titled "Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations". The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).
What is the current status of trial NCT02260388?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 402 participants. The study started on 2014-10. Estimated completion is 2017-09.
What interventions are being tested in trial NCT02260388?
The interventions under investigation include: Duloxetine (DRUG), Pregabalin (DRUG), Nortriptyline (DRUG), Mexiletine (DRUG).
Who is sponsoring clinical trial NCT02260388?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02260388's enrollment target sits among peer trials
402 210th of 2000 higher than 1,791 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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