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).
Cryptogenic Sensory Polyneuropathy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)|
- Change in patient-reported pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Patients will complete a Likert-type scale for pain at each visit, the Patient Reported Outcome Measurement Information System (PROMIS) 6 item pain interference scale. Final measurement is based on the change in pain score at the end of 12 weeks.
- Percentage of patients who discontinue treatment [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
- Change in general health and well being [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Change will be measured using the SF-12 questionnaire.
- Pain interference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure of how pain and how it may interfere with multiple aspects of each participants life. Changes will be measured using the NIH Pain Interference Scale.
- Change in Fatigue [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]Participants will complete NIH Fatigue Interference Scale at study visits. Responses will measure change in how often, how long, how intense a participant's fatigue is and how fatigue affects their life.
- Quality of Sleep [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Participants will complete NIH Sleep Disturbance Scale at study visits. Scale measures quality and length of sleep. Outcome measured by change in scores from baseline visit to end of study/week 12 visit.
|Study Start Date:||October 2014|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
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.
Duloxetine - 20 mg daily for 1 week, then 40 mg daily for 1 week, then 60 mg daily for the remainder of the study.
Pregabalin - 100 mg, 3 times per day.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02260388
|Contact: Laura Herbelin||(913) 588-5095||LHERBELIN@kumc.edu|
|United States, Arizona|
|Barrow Neurological Institute||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Gale Kittle 602-406-6262 Gale.Kittle@DignityHealth.org|
|Principal Investigator: Shafeeq Ladha, MD|
|Phoenix Neurological Associates||Recruiting|
|Phoenix, Arizona, United States, 85018|
|Contact: Lynette McKinney 602-258-3354 LMcKinney@pnal.net|
|Principal Investigator: David Saperstein, MD|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Y-Nhy Duong 415-502-2128 firstname.lastname@example.org|
|Principal Investigator: Jeffrey Ralph, MD|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Sandy Guingrich 317-963-7382 email@example.com|
|Principal Investigator: Robert Pascuzzi, MD|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|United States, North Dakota|
|Fargo, North Dakota, United States, 58122|
|Contact: Patricia Skarloken 701-234-4091 Patricia.firstname.lastname@example.org|
|Principal Investigator: Jau-Shin Lou, MD|
|United States, Pennsylvania|
|Penn State Medical Center||Recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Contact: Heidi Runk 717-531-0003 email@example.com|
|Contact: Anne Morris 717-531-0003 firstname.lastname@example.org|
|Principal Investigator: Matthew Wicklund, MD|
|United States, Texas|
|Sara Austin, MD, PA||Recruiting|
|Austin, Texas, United States, 78705|
|Contact: Sue Holstrom, RN, OCN 512-637-5854 email@example.com|
|Principal Investigator: Sara Austin, MD|
|Dallas, Texas, United States, 75214|
|Contact: Todd Morgan 214-279-0310 firstname.lastname@example.org|
|Principal Investigator: Daragh Heitzman, MD|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Cathy Revere 801-585-9516 email@example.com|
|Principal Investigator: Gordon Smith, MD|
|Principal Investigator:||Richard Barohn, MD||University of Kansas|