Trial record 2 of 21 for:    neurology AND University AND San Francisco | Open Studies | Exclude Unknown

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 June 2015 by University of Kansas
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT02260388
First received: October 6, 2014
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

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:

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 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.


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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT02260388

Contacts
Contact: Laura Herbelin (913) 588-5095 LHERBELIN@kumc.edu

Locations
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
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Peggy Allred, PT DPT    424-315-2694    Peggy.allred@cshs.org   
Principal Investigator: Richard Lewis, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Y-Nhy Duong    415-502-2128    nhy-y.duong@ucsf.edu   
Principal Investigator: Jeffrey Ralph, MD         
United States, Florida
University of Florida Health Science Center - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Lisa Smith    904-244-9480      
Principal Investigator: Michael Pulley, MD, PhD         
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Monica Quesada    305-243-7424    mquesada2@med.miami.edu   
Principal Investigator: Khema Sharma, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sandy Guingrich    317-963-7382    sguingri@iupui.edu   
Principal Investigator: Robert Pascuzzi, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, North Dakota
Sanford Health Recruiting
Fargo, North Dakota, United States, 58122
Contact: Patricia Skarloken    701-234-4091    Patricia.skarloken@sanfordhealth.org   
Principal Investigator: Jau-Shin Lou, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Irys Caristo    216-444-0173    CARISTI@ccf.org   
Principal Investigator: Yuebing Li, MD, PhD         
United States, Pennsylvania
Penn State Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Heidi Runk    717-531-0003    hrunk@hmc.psu.edu   
Contact: Anne Morris    717-531-0003    amorris2@hmc.psu.edu   
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    sue.draustinsoffice@gmail.com   
Principal Investigator: Sara Austin, MD         
Texas Neurology Recruiting
Dallas, Texas, United States, 75214
Contact: Todd Morgan    214-279-0310    tmorgan@texasneurology.com   
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    u0357661@utah.edu   
Principal Investigator: Gordon Smith, MD         
Sponsors and Collaborators
University of Kansas
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Richard Barohn, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT02260388     History of Changes
Other Study ID Numbers: STUDY00001500, PCORI-1306-02496
Study First Received: October 6, 2014
Last Updated: June 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
CSPN
neuropathy
pain
pain management

Additional relevant MeSH terms:
Polyneuropathies
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Duloxetine
Mexiletine
Nortriptyline
Pregabalin
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Anti-Arrhythmia Agents
Anticonvulsants
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

ClinicalTrials.gov processed this record on July 01, 2015