Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
NCT ID: NCT02260388
Last Updated: 2018-07-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
402 participants
INTERVENTIONAL
2014-10-31
2017-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nortriptyline
Nortriptyline - 25 mg daily for 1 week at bedtime, then 50 mg daily at bedtime for 1 week, then 75 mg daily at bedtime for the remainder of the study.
Nortriptyline
Duloxetine
Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.
Duloxetine
Pregabalin
Pregabalin - 100 mg at bedtime for 1 week, then 100 mg 2 times per day for 1 week, then 100 mg 3 times per day for the remainder of the study.
Pregabalin
Mexiletine
Mexiletine - 200 mg at bedtime for 1 week, then 200 mg 2 times per day for 1 week, then 200 mg 3 times per day for the remainder of the study.
Mexiletine
Interventions
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Nortriptyline
Duloxetine
Pregabalin
Mexiletine
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to give consent.
* Unable or not willing to comply with the study.
* Other causes for polyneuropathy.
30 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Richard Barohn, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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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
University of Nebraska Medical Center
Omaha, Nebraska, United States
University of Buffalo School of Medicine and Biomedical Sciences
Buffalo, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Penn State Medical Center
Hershey, Pennsylvania, United States
Austin Neuromuscular Center
Austin, Texas, United States
Sara Austin, MD, PA
Austin, Texas, United States
Seton Brain and Spine Institute
Austin, Texas, United States
Texas Neurology
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health Science Center at Houton
Houston, Texas, United States
Grand Medical Clinic
Katy, Texas, United States
Neurology Clinic of Central Texas
New Braunfels, Texas, United States
University of Texas Health Science Center in San Antonio
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Barohn RJ, Gajewski B, Pasnoor M, Brown A, Herbelin LL, Kimminau KS, Mudaranthakam DP, Jawdat O, Dimachkie MM; Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS) Study Team; Iyadurai S, Stino A, Kissel J, Pascuzzi R, Brannagan T, Wicklund M, Ahmed A, Walk D, Smith G, Quan D, Heitzman D, Tobon A, Ladha S, Wolfe G, Pulley M, Hayat G, Li Y, Thaisetthawatkul P, Lewis R, Biliciler S, Sharma K, Salajegheh K, Trivedi J, Mallonee W, Burns T, Jacoby M, Bril V, Vu T, Ramchandren S, Bazant M, Austin S, Karam C, Hussain Y, Kutz C, Twydell P, Scelsa S, Kushlaf H, Wymer J, Hehir M, Kolb N, Ralph J, Barboi A, Verma N, Ahmed M, Memon A, Saperstein D, Lou JS, Swenson A, Cash T. Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial. JAMA Neurol. 2021 Jan 1;78(1):68-76. doi: 10.1001/jamaneurol.2020.2590.
Brown AR, Gajewski BJ, Aaronson LS, Mudaranthakam DP, Hunt SL, Berry SM, Quintana M, Pasnoor M, Dimachkie MM, Jawdat O, Herbelin L, Barohn RJ. A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization. Trials. 2016 Aug 31;17(1):428. doi: 10.1186/s13063-016-1544-5.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PCORI-1306-02496
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00001500
Identifier Type: -
Identifier Source: org_study_id
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