Cryptogenic Sensory Polyneuropathy Clinical Trial
— PAIN-CONTRoLSOfficial title:
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)
| Verified date | June 2018 |
| Source | University of Kansas Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 402 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Toronto General Hospital | Toronto | Ontario |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | University of Colorado Denver Anschutz Campus | Aurora | Colorado |
| 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 | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | University of Buffalo School of Medicine and Biomedical Sciences | Buffalo | New York |
| United States | University of Vermont Medical Center | Burlington | Vermont |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Colorado Springs Neurological Associates | Colorado Springs | Colorado |
| United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
| United States | Texas Neurology | Dallas | Texas |
| United States | University of Texas Southwestern | Dallas | Texas |
| United States | Mercy Medical Center - Des Moines | Des Moines | Iowa |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | University of Florida - Gainesville | Gainesville | Florida |
| United States | NorthShore Neurological Institute | Glenview | Illinois |
| United States | Spectrum Health System | Grand Rapids | Michigan |
| United States | Penn State Medical Center | Hershey | Pennsylvania |
| United States | University of Texas Health Science Center at Houton | Houston | Texas |
| United States | Hutchinson Clinic, PA | Hutchinson | Kansas |
| United States | Indiana University | Indianapolis | Indiana |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | University of Florida Health Science Center - Jacksonville | Jacksonville | Florida |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Grand Medical Clinic | Katy | Texas |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Norton Neurology Services | Louisville | Kentucky |
| United States | University of Miami Miller School of Medicine | Miami | Florida |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Neurology Clinic of Central Texas | New Braunfels | Texas |
| United States | Mount Sinai Beth Israel | New York | New York |
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| United States | Neurological Services of Orlando Research | Orlando | Florida |
| United States | Barrow Neurological Institute | Phoenix | Arizona |
| United States | Phoenix Neurological Associates | Phoenix | Arizona |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | University of Utah | Salt Lake City | Utah |
| United States | University of Texas Health Science Center in San Antonio | San Antonio | Texas |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | University of South Florida | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Kansas Medical Center | Patient-Centered Outcomes Research Institute |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | 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 | SF12 Health Composite Scores | SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view. Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. Scores are calibrated so that 50 is the average score or norm, standard deviation = 10. Higher scores indicate better health for both mental and physical component summary scores. |
12 weeks | |
| Secondary | PROMIS Pain Interference Short Form v1.0 8a T Score | Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population. |
12 weeks | |
| Secondary | PROMIS Fatigue Short Form v1.0 8a | Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population. |
12 Weeks | |
| Secondary | PROMIS Sleep Disturbance Short Form v1.0 8a | Higher scores for sleep disturbance represents worse outcome (more sleep disturbance). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population. Higher scores equals more of the concept being measured |
12 weeks |