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



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - Any
Updated:7/8/2018
Start Date:October 2014
End Date:September 2017

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Trial Summary
Trial Overview
Inclusion Criteria

Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)

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).

The goal of this research project is to find the best drug for the treatment of pain in
patients with CSPN. While the pharmaceutical industry has focused attention on drugs for
treating diabetic sensory neuropathy (DSPN), and two drugs are now FDA approved, there have
not been any prospective trials in CSPN. And, because there are no studies with CSPN
patients, insurance carriers often reject authorizing prescriptions for some drugs for
patients with CSPN.

There are four drugs that will be tested in this study: nortriptyline, duloxetine, pregabalin
and mexiletine. These drugs are not approved by the FDA for the treatment of CSPN and are
considered "investigational" in this study.

There are two periods in this study: Screening/Baseline and Study Drug. During the
Screening/Baseline period the researchers will determine eligibility for potential subjects.
During the second period, eligible patients who consented to participate will take the study
drug. Participants will be randomized to receive one of the four drugs in this study.
Participants will know which drug they are taking. Participants will not be allowed to switch
groups and receive a different drug during the study.

This study uses an adaptive study design. This means the study can enroll less participants
and provide better conclusions. The study design allows the researchers the ability to make
changes to the approach of the study or to stop the study early if there are strong results.

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.
We found this trial at
46
sites
Univ of Nebraska Med Ctr
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Pariwat Thaisetthawatkul, MD
Phone: 402-552-6246
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Brigham and Women's Hosp
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Mohammad Kian Salajegheh, MD
Phone: 617-525-6497
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Yuebing Li, MD, PhD
Phone: 216-444-0173
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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University of Florida Gainesville
Gainesville, Florida 32611
(352) 392-3261
Principal Investigator: James Wymer, MD, PhD
Phone: 352-273-5566
University of Florida Gainesville UF has a long history of established programs in international education,...
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Gainesville, FL
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Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Robert Pascuzzi, MD
Phone: 317-963-7382
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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University of Florida Health Science Center - Jacksonville
655 West 8th Street
Jacksonville, Florida 32209
Principal Investigator: Michael Pulley, MD, PhD
Phone: 904-244-9814
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Jacksonville, FL
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Richard Lewis, MD
Phone: 424-315-2694
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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University of Miami Miller School of Medicine
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
Principal Investigator: Khema Sharma, MD
Phone: 305-243-7424
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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Univ of Minnesota
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: David Walk, MD
Phone: 612-624-5978
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Phoenix Neurological Associates
5090 N 40th St # 250
Phoenix, Arizona 85018
Principal Investigator: David Saperstein, MD
Phone: 602-258-3354
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Chafic Karam, MD
Phone: 503-494-7269
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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University of Utah
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Gordon Smith, MD
Phone: 801-585-2741
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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University of Texas Health Science Center at San Antonio
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Alejandro Tobon-Gonzalez, MD
Phone: 210-450-0524
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Tuan Vu, MD
Phone: 813-974-9413
University of South Florida The University of South Florida is a high-impact, global research university...
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Tampa, FL
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Sindhu Ramchandren, MD
Phone: 734-647-9224
University of Michigan The University of Michigan was founded in 1817 as one of the...
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University of Colorado Denver Anschutz Campus
Aurora, Colorado 80045
Principal Investigator: Dianna Quan, MD
Phone: 303-724-6247
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Sara Austin, MD, PA
Austin, Texas 78705
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Austin, TX
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Seton Brain & Spine Institute
Austin, Texas 78701
Principal Investigator: Sara Austin, MD
Phone: 513-324-8300
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Austin, TX
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Austin Neuromuscular Center
Austin, Texas 78703
Principal Investigator: Yessar Hussain, MD
Phone: 512-920-0140
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Austin, TX
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University of Buffalo School of Medicine and Biomedical Sciences
Buffalo, New York 14203
Principal Investigator: Gil Wolfe, MD, FAAN
Phone: 716-859-7510
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Buffalo, NY
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University of Vermont Medical Center
Burlington, Vermont 05405
Principal Investigator: Michael Hehir, MD
Phone: 802-733-5779
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Burlington, VT
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University of Virginia
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Ted Burns, MD
Phone: 434-982-0293
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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University of Cincinnati
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Hani Kushlaf, MD
Phone: 513-558-0039
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Colorado Springs Neurological Associates
Colorado Springs, Colorado 80907
Principal Investigator: Laurence Adams, MD
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Colorado Springs, CO
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The Ohio State University, Wexner Medical Center
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Stanley Iyadurai, MSc, PhD, MD
Phone: 614-688-7837
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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University of Texas Southwestern
Dallas, Texas 75390
Principal Investigator: Jaya Trivedi, MD
Phone: 214-648-0462
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Texas Neurology, PA
Dallas, Texas 75214
Principal Investigator: Daragh Heitzman, MD
Phone: 214-279-0310
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Mercy Medical Center - Des Moines
1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Principal Investigator: Michael Jacoby, MD
Phone: 515-238-7361
Mercy Medical Center - Des Moines Mercy Medical Center
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Henry Ford Hospital
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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NorthShore Neurological Institute
2180 Pfingsten Road
Glenview, Illinois 60026
Principal Investigator: Alexandru Barboi, MD
Phone: 847-503-4322
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Glenview, IL
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Spectrum Health System
Grand Rapids, Michigan 49503
Principal Investigator: Paul Twydell, DO
Phone: 616-218-0311
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Grand Rapids, MI
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Penn State Medical Center
Hershey, Pennsylvania 17033
Principal Investigator: Matthew Wicklund, MD
Phone: 717-531-0003
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Hershey, PA
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University of Texas Health Science Center at Houton
Houston, Texas 77030
Principal Investigator: Suur Biliciler, MD
Phone: 713-500-6785
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Houston, TX
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Hutchinson Clinic
Hutchinson, Kansas 67502
Principal Investigator: William Mallonee, MD
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Hutchinson, KS
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Andrea Swenson, MD
Phone: 319-356-8744
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Phone: 913-945-9932
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Grand Medical Clinic
2830 Commercial Center Boulevard
Katy, Texas 77494
Principal Investigator: Moiz Ahmed, MD
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Katy, TX
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Norton Neurology Services
Louisville, Kentucky 40207
Principal Investigator: Mark Bazant, MD
Phone: 502-629-3376
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Louisville, KY
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Neurology Clinic of Central Texas
New Braunfels, Texas 78132
Principal Investigator: Bill Davis, MD
Phone: 830-606-9142
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New Braunfels, TX
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Mount Sinai Beth Israel
New York, New York 10003
Principal Investigator: Stephen Scelsa, MD
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New York, NY
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Neurological Services of Orlando Research
Orlando, Florida 32806
Principal Investigator: Navin Verma, MD
Phone: 407-240-1762
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Orlando, FL
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Barrow Neurological Institute
Phoenix, Arizona 85013
Principal Investigator: Shafeeq Ladha, MD
Phone: 602-406-6262
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Saint Louis University
Saint Louis, Missouri 63110
Principal Investigator: Ghazala Hayat, MD
Phone: 314-302-6426
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Saint Louis, MO
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California Pacific Medical Center
45 Castro Street
San Francisco, California 94114
(415) 600-6000
Principal Investigator: Johnathan Katz, MD
Phone: 415-824-1172
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, CA
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University of California at San Francisco
San Francisco, California 94143
Principal Investigator: Jeffrey Ralph, MD
Phone: 415-502-2128
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San Francisco, CA
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Toronto General Hospital
Toronto, Ontario
Principal Investigator: Vera Bril, MD, FRCPC
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