NCT02260388

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Cryptogenic Sensory Polyneuropathy

Interventions

Type	Name	Description
DRUG	Nortriptyline
DRUG	Duloxetine
DRUG	Pregabalin
DRUG	Mexiletine

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-10-09
• Last updated: 2018-07-06
• Results posted: 2018-07-06

Locations

46 sites across 2 countries: United States, Canada