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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Kansas Medical Center
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
University of Kansas Medical Center Identifier:
First received: October 6, 2014
Last updated: November 10, 2015
Last verified: November 2015
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).

Condition Intervention Phase
Cryptogenic Sensory Polyneuropathy
Drug: Nortriptyline
Drug: Duloxetine
Drug: Pregabalin
Drug: Mexiletine
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 Short Form Health Survey (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 National Institutes of Health (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.

Estimated Enrollment: 400
Study Start Date: October 2014
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Nortriptyline
Experimental: 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.
Drug: Duloxetine
Experimental: 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.
Drug: Pregabalin
Experimental: 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.
Drug: Mexiletine

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.


Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 (Appendix F) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02260388

Contact: Maureen Walsh (913)588-0645

  Show 24 Study Locations
Sponsors and Collaborators
University of Kansas Medical Center
Patient Centered Outcome Research Institute
Principal Investigator: Richard Barohn, MD University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: University of Kansas Medical Center Identifier: NCT02260388     History of Changes
Other Study ID Numbers: STUDY00001500, PCORI-1306-02496
Study First Received: October 6, 2014
Last Updated: November 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
pain management

Additional relevant MeSH terms:
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Arrhythmia Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents processed this record on November 25, 2015