Phase 4
N=402
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
Cryptogenic Sensory Polyneuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02260388 ↗Enrolled (actual)
402
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit — 34; 29; 11; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Nortriptyline (Drug); Duloxetine (Drug); Pregabalin (Drug); Mexiletine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit |
34; 29; 11; 14; 49; 50 | — |
| SECONDARY SF12 Health Composite Scores |
51.0; 50.9; 47.2; 51.3; 42.8; 42.1 | — |
| SECONDARY PROMIS Pain Interference Short Form v1.0 8a T Score |
56.4; 56.5; 60.0; 54.5 | — |
| SECONDARY PROMIS Fatigue Short Form v1.0 8a |
53.6; 55.4; 56.7; 51.6 | — |
| SECONDARY PROMIS Sleep Disturbance Short Form v1.0 8a |
58.9; 58.9; 58.3; 59.1 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of cryptogenic sensory polyneuropathy.
- Likert Pain Score of greater than or equal to 4.
- Must not currently be on nortriptyline, duloxetine, pregabalin or mexiletine or similar class of medication for at least 7 days from baseline study visit.
Exclusion Criteria
- Any medical condition or current medication that would prevent them from taking either nortriptyline, duloxetine, pregabalin or mexiletine.
- Unable to give consent.
- Unable or not willing to comply with the study.
- Other causes for polyneuropathy.
Data sourced from ClinicalTrials.gov (NCT02260388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.