Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations
PAIN-CONTRoLS
2 other identifiers
interventional
402
2 countries
46
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2014
Typical duration for phase_4
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 6, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
July 6, 2018
CompletedJuly 6, 2018
June 1, 2018
2.9 years
October 6, 2014
March 2, 2018
June 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.
12 weeks
Secondary Outcomes (4)
SF12 Health Composite Scores
12 weeks
PROMIS Pain Interference Short Form v1.0 8a T Score
12 weeks
PROMIS Fatigue Short Form v1.0 8a
12 Weeks
PROMIS Sleep Disturbance Short Form v1.0 8a
12 weeks
Study Arms (4)
Nortriptyline
EXPERIMENTALNortriptyline - 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.
Duloxetine
EXPERIMENTALDuloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.
Pregabalin
EXPERIMENTALPregabalin - 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.
Mexiletine
EXPERIMENTALMexiletine - 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.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Phoenix Neurological Associates
Phoenix, Arizona, 85018, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
California Pacific Medical Center
San Francisco, California, 94107, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Colorado Denver Anschutz Campus
Aurora, Colorado, 80045, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
University of Florida - Gainesville
Gainesville, Florida, 10236, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Neurological Services of Orlando Research
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33612, United States
NorthShore Neurological Institute
Glenview, Illinois, 60026, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Hutchinson Clinic, PA
Hutchinson, Kansas, 67502, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Neurology Services
Louisville, Kentucky, 40207, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48105, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Spectrum Health System
Grand Rapids, Michigan, 49525, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Saint Louis University
St Louis, Missouri, 63103, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of Buffalo School of Medicine and Biomedical Sciences
Buffalo, New York, 14203, United States
Mount Sinai Beth Israel
New York, New York, 10029, United States
University of Cincinnati
Cincinnati, Ohio, 45221, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Penn State Medical Center
Hershey, Pennsylvania, 17033, United States
Austin Neuromuscular Center
Austin, Texas, 78703, United States
Sara Austin, MD, PA
Austin, Texas, 78705, United States
Seton Brain and Spine Institute
Austin, Texas, 78705, United States
Texas Neurology
Dallas, Texas, 75214, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
University of Texas Health Science Center at Houton
Houston, Texas, 77030, United States
Grand Medical Clinic
Katy, Texas, 77494, United States
Neurology Clinic of Central Texas
New Braunfels, Texas, 78132, United States
University of Texas Health Science Center in San Antonio
San Antonio, Texas, 78229, United States
University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont Medical Center
Burlington, Vermont, 05403, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Related Publications (2)
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.
PMID: 32809014DERIVEDBrown 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.
PMID: 27577191DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard Barohn
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Barohn, MD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2014
First Posted
October 9, 2014
Study Start
October 1, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
July 6, 2018
Results First Posted
July 6, 2018
Record last verified: 2018-06