Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations

Completed · Phase 4

Conditions studied: Cryptogenic Sensory Polyneuropathy

In brief

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).

Key facts

Study ID

NCT02260388

Run by

University of Kansas Medical Center

People needed

402

Starts

2014-10-01

Expected to finish

2017-09-01

Last updated by the study team

2018-07-06

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• Phoenix Neurological Associates — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Colorado Denver Anschutz Campus — Aurora, Colorado, United States
• Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• University of Florida Health Science Center - Jacksonville — Jacksonville, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Neurological Services of Orlando Research — Orlando, Florida, United States
• University of South Florida — Tampa, Florida, United States
• NorthShore Neurological Institute — Glenview, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Hutchinson Clinic, PA — Hutchinson, Kansas, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Neurology Services — Louisville, Kentucky, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Spectrum Health System — Grand Rapids, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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