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EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA (EN21-01)

Primary Purpose

Painful Diabetic Neuropathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NRD135SE.1
Placebo
Sponsored by
James P. Rathmell, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(To be used in conjunction with Platform Protocol criteria.)

  1. At the time of screening (V1), a documented diagnosis of stable Type II diabetes mellitus with painful diabetic peripheral neuropathy of at least 6 months' duration with BOTH of the following as confirmed by a physician trained for the study:

    1. Neuropathic symptoms in a distal distribution (e.g., numbness, paresthesia or tingling, sensory distortions or misinterpretations, etc.)
    2. Decreased distal sensation (e.g., decreased vibration, pinprick sensation, light touch, etc.)
  2. A score β‰₯3 on the Michigan Neuropathy Screening Instrument (MNSI) part B. Diagnosis must be carried out by trained personnel.
  3. At the time of screening (V1) at least 40 mm on a 100-mm visual analog scale (VAS) for average pain over the previous 24 hours.
  4. Patient-reported daily 11-point NRS (for average pain over the last 24 hours) meets the criteria specified in "Appendix B: Blinded Information" during both the 7-day screening and 7-day baseline periods. The algorithm will be assessed centrally.

Exclusion Criteria:

(To be used in conjunction with Platform Protocol criteria.) Participants fulfilling any of the following criteria are not eligible for the study.

  1. Females of childbearing potential will be excluded. Any of the following criteria will suffice to confirm a female's inability to bear children:

    1. Previous bilateral salpingectomy, bilateral salpingo-oophorectomy, or hysterectomy;
    2. Postmenopausal state (defined as 12 consecutive months of spontaneous amenorrhea without an alternative medical reason in a woman of at least 50 years of age);
    3. Premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, uterine agenesis.
  2. Body mass index of > 40 kg/m2.
  3. Diagnosis of alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 2 years before the Screening visit.
  4. Moderate or severe renal impairment, known (documented) or defined as an estimated/calculated creatinine clearance/estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, according to the Chronic Kidney Disease Epidemiology Collaboration formula.
  5. Any of the following conditions related to corrected QT intervals using Fridericia's formula (QTcF):

    1. A QTcF > 500 ms prior to starting IP.
    2. A history of the following additional risk factors for torsade de pointes: heart failure, hypokalemia, history or family history of long QT syndrome.
  6. History of myocardial infarction, arrhythmia, other significant heart disease, or stroke.
  7. History of gastric surgery that might be expected to alter normal absorption of the IP (e.g., gastric bypass).
  8. Participants known to have participated in four or more studies for investigational pain drugs.
  9. Participants known to be non-responders to more than three previous neuropathic pain medications at adequate doses over at least 4 weeks or to have discontinued more than three such medications due to tolerability. Adequate doses (given as total daily doses) are defined as follows: 1,800 mg gabapentin; 300 mg pregabalin; opioid analgesics 60 mg oxycodone equivalent or 200 mg tramadol; 75 mg amitriptyline or equivalent tricyclic antidepressant; 60 mg duloxetine; 150 mg venlafaxine.
  10. Known hypersensitivity or contraindication to any excipients of the study drug formulation.
  11. Taking prohibited medications as described in Section 12, "Concomitant Therapy," and Appendix A, "Prohibited Medications."
  12. Major depressive episode within the 6 months before screening and/or a history of diagnosed recurrent major depressive disorder.
  13. Any of the following conditions related to suicidality:

    1. Any suicidal ideation with intent, with or without a plan, at screening, i.e., answering "yes" to questions 4 or 5 on the Suicidal Ideation section of the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS);
    2. Answering "yes" on any item of the Suicidal Behavior Section (except for the "non-suicidal self-injurious behavior") of the C-SSRS if this behavior occurred in the past 2 years;
    3. A lifetime history of suicide attempt (V1).
  14. Previous known or possible exposure to NRD135S.E1.

Sites / Locations

  • University of California, San DiegoRecruiting
  • South Lake Pain InstituteRecruiting
  • University of FloridaRecruiting
  • Northwestern Department of NeurologyRecruiting
  • MGH Department of Anesthesia, Critical Care, and PainRecruiting
  • Mount Sinai School of MedicineRecruiting
  • Columbia University Medical Center/Neurological InstituteRecruiting
  • University of RochesterRecruiting
  • University of PittsburghRecruiting
  • VCU Department of NeurologyRecruiting
  • University of WashingtonRecruiting
  • University of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NRD135S.E1 80mg/day

Matching placebo

Arm Description

NRD135S.E1 as a potential treatment for moderate to severe painful diabetic peripheral neuropathy (PDPN). While the activity of NRD135S.E1 has been extensively studied, its molecular target is not known, though it does not appear to work through any of the opioid receptors or molecular pathways currently targeted by available analgesics. The best evidence suggests it may act, at least in part, through modulating the Lyn kinase signaling pathway In clinical studies, NRD135S.E1 has been well tolerated at all dose levels tested in single-dose (up to 1,200 mg) and repeat-dose regimens (up to 300 mg/day over 5 days or 150 mg over 3 weeks), and it has been shown to have predictable pharmacokinetics with dose-dependent increases in exposure.

A matching placebo comparator will be used.

Outcomes

Primary Outcome Measures

To demonstrate that NRD135S.E1 80 mg daily is superior to placebo in relieving neuropathic pain associated with PDPN, after 13 weeks' treatment.
Change from Baseline to Week 13 in the weekly mean of the daily 24-hour average pain measured by Numeric Rating Scale (NRS) (abbreviated herein as WAP for weekly average pain). The NRS is a 0-10 scale, with 0 indicating no pain, and 10 being the worst possible pain.
The frequency (i.e. number of participants) with treatment emergent adverse events (TEAEs) reported in the time period defined by first administration of IP until 7 days after the last dose of IP.
A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of study treatment whether or not considered by the investigator as related to study treatment.

Secondary Outcome Measures

Occurrence of 30% reduction of WAP from Baseline to Week 13.
Weekly Average Pain is abbreviated as WAP.
Occurrence of 50% reduction of WAP from Baseline to Week 13.
Weekly Average Pain is abbreviated as WAP.

Full Information

First Posted
July 25, 2022
Last Updated
July 26, 2023
Sponsor
James P. Rathmell, MD
Collaborators
New York University, Icahn School of Medicine at Mount Sinai, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05480228
Brief Title
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
Acronym
EN21-01
Official Title
EPPIC-Net EN21-01 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of 80 mg Daily of NRD135S.E1 Versus Placebo in Adult and Elderly Participants With Painful Diabetic Peripheral Neuropathy.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James P. Rathmell, MD
Collaborators
New York University, Icahn School of Medicine at Mount Sinai, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.
Detailed Description
This ISA describes a double-blind Phase II study of the PK/PD, safety, tolerability, and effect of 13 weeks of NRD135S.E1 (80mg/day) as an ISA within the context of the Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy, EN21-PP. The ISA is intended to be read and interpreted within the context of the Platform Protocol and focuses on the description of design features that are specific to NRD135S.E1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study is an interventional, prospective, parallel-group, multicenter, randomized, double-blind, placebo-controlled, Phase 2 study.
Masking
ParticipantInvestigator
Masking Description
Randomization assignment will be blinded from study participants, staff from clinical sites, investigators, asset owner, IND sponsors, and/or designees.
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NRD135S.E1 80mg/day
Arm Type
Experimental
Arm Description
NRD135S.E1 as a potential treatment for moderate to severe painful diabetic peripheral neuropathy (PDPN). While the activity of NRD135S.E1 has been extensively studied, its molecular target is not known, though it does not appear to work through any of the opioid receptors or molecular pathways currently targeted by available analgesics. The best evidence suggests it may act, at least in part, through modulating the Lyn kinase signaling pathway In clinical studies, NRD135S.E1 has been well tolerated at all dose levels tested in single-dose (up to 1,200 mg) and repeat-dose regimens (up to 300 mg/day over 5 days or 150 mg over 3 weeks), and it has been shown to have predictable pharmacokinetics with dose-dependent increases in exposure.
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
A matching placebo comparator will be used.
Intervention Type
Drug
Intervention Name(s)
NRD135SE.1
Other Intervention Name(s)
NRD135s.E1, a small chemical entity for treatment of neuropathic pain
Intervention Description
The double-blind treatment phase is up to 13 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A matching placebo will be taken for up to 13 weeks.
Primary Outcome Measure Information:
Title
To demonstrate that NRD135S.E1 80 mg daily is superior to placebo in relieving neuropathic pain associated with PDPN, after 13 weeks' treatment.
Description
Change from Baseline to Week 13 in the weekly mean of the daily 24-hour average pain measured by Numeric Rating Scale (NRS) (abbreviated herein as WAP for weekly average pain). The NRS is a 0-10 scale, with 0 indicating no pain, and 10 being the worst possible pain.
Time Frame
13 weeks
Title
The frequency (i.e. number of participants) with treatment emergent adverse events (TEAEs) reported in the time period defined by first administration of IP until 7 days after the last dose of IP.
Description
A treatment-emergent adverse event (TEAE) is any AE temporally associated with the use of study treatment whether or not considered by the investigator as related to study treatment.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Occurrence of 30% reduction of WAP from Baseline to Week 13.
Description
Weekly Average Pain is abbreviated as WAP.
Time Frame
13 weeks
Title
Occurrence of 50% reduction of WAP from Baseline to Week 13.
Description
Weekly Average Pain is abbreviated as WAP.
Time Frame
13 weeks
Other Pre-specified Outcome Measures:
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to Pain Catastrophizing Scale - Short Form 6 (PCS-SF6)
Description
Catastrophizing is a pain-specific psychosocial construct comprising cognitive and emotional processes such as helplessness, pessimism, rumination about pain-related symptoms, and magnification of pain reports. The PCS-SF6 is a 6-item, self-report measure of catastrophic thinking associated with pain. Scores range from 0-24, with higher scores indicating more catastrophizing.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Pain, Enjoyment, and General activity scale (PEG).
Description
The PEG is a three-item (each scored 0-10) multidimensional pain measure designed and validated for use in primary care and other ambulatory clinic patients, as a practical and useful tool to improve assessment and monitoring of chronic pain in primary care.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the PROMIS Physical Functioning Short-Form 6b
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning short form is a 6-item scale that is widely used in pain research. It is a unidimensional scale that shows broad coverage of the physical function construct, good construct validity, and high levels of temporal stability. The PROMIS Physical Function Scale is expressed as a T-score, with a population mean of 50 and SD of 10. Higher scores represent better physical functioning; possible T scores in this distribution range from 21 to 59 (PROMIS, 2020).
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Pain Health Questionnaire (PHQ-2).
Description
The 2-item PHQ-2 is a brief depression screening tool that correlates strongly with PHQ-9 scores and shows good sensitivity for identifying individuals with depressive disorders in the general population in a variety of medical samples. Scores range from 0-6, with higher scores indicating more depressive symptomatology.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Generalized Anxiety Disorder - 2 item scale (GAD-2).
Description
The GAD-2 is a 2-item screening tool that is widely used to screen for clinically significant anxiety symptoms and anxiety disorders in clinical settings. It shows good sensitivity and specificity as a screening tool for anxiety disorders. Scores range from 0-6, with higher scores indicating more anxiety symptomatology.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Tobacco, Alcohol, Prescription medication, and other Substance use Tool (TAPS-1).
Description
The TAPS-1 is the screening component of the TAPS tool and consists of a single stem question with four items covering the frequency of past-12-month use of tobacco, alcohol, and illicit drugs, and non-medical use of prescription medications. Scores range from 0-4; higher scores indicate a higher likelihood of problematic substance use. The TAPS-1 shows good sensitivity and specificity for identifying substance use disorders.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the PROMIS Sleep Disturbance - 6A.
Description
The PROMIS Sleep Disturbance short form is a convenient 6-item scale that correlates strongly with the longer forms. The PROMIS Sleep Disturbance Scale is expressed as a T-score, with a population mean of 50 and standard deviation (SD) of 10. Possible T scores in this distribution range from 31.7 to 76.1 (PROMIS, 2021).
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Sleep Duration Scale.
Description
A single-item scale measuring the duration of actual sleep a participant has gotten, on average, over the past month. Numerical responses will be provided in hours and minutes.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Opioid Use Questionnaire (OUQ).
Description
The OUQ is an indicator of past or present use of any of the listed opioid medications. There are a total of three yes/no items where a yes indicates the use of such medications.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Patient Global Impression of Change (PGIC).
Description
The PGIC is a single-item measure of patient-reported improvement that is widely used as a general outcome measure in studies of chronic pain patients. It is often used as an index of treatment-associated change, and patient-reported improvements in the form of PGIC scores correlate robustly with significant improvement in pain intensity, pain interference with activities of daily living, mood, and quality of life (Perrot and Lanteri-Minet, 2019).
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN)
Description
The Norfolk QOL-DN is a validated 47-item, patient-reported outcome measure, sensitive to the different features of diabetic neuropathy (DN) including small fiber, large fiber, and autonomic function. A higher score indicates higher levels of neuropathic pain.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Neuropathy examination.
Description
The neuropathy examination will be a single procedure consisting of visual inspection of the feet, brief distal motor exam, ankle and knee deep tendon reflexes, and a standardized sensory exam. This exam will collect the data needed to calculate several common scores including: the Michigan Neuropathy Screening Instrument (MNSI) Part B, the Utah Early Neuropathy Scale (UENS) and the Toronto Clinical Scoring System (TCNS). The MSNI Part B consists of visual inspection of the feet and assessment of ankle reflexes, vibration sense, and monofilament testing. The TCNS is quantitative scoring system for evaluating the severity of peripheral neuropathy. Most of the test is done on or near the toes, light touch testing is done with a 10gm monofilament fiber. The UENS consists of testing the distal lower extremities for motor function, sharp sensation, allodynia, vibration sensation, and deep tendon reflexes. It is scored on a scale of 0-42 where zero is normal.
Time Frame
13 weeks
Title
To assess the effect of NRD135S.E1 in comparison to placebo with respect to the actigraphy step count.
Description
Mean daily step counts will be used as an index of physical activity.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (To be used in conjunction with Platform Protocol criteria.) At the time of screening (V1), a documented diagnosis of stable Type II diabetes mellitus with painful diabetic peripheral neuropathy of at least 6 months' duration with BOTH of the following as confirmed by a physician trained for the study: Neuropathic symptoms in a distal distribution (e.g., numbness, paresthesia or tingling, sensory distortions or misinterpretations, etc.) Decreased distal sensation (e.g., decreased vibration, pinprick sensation, light touch, etc.) A score β‰₯3 on the Michigan Neuropathy Screening Instrument (MNSI) part B. Diagnosis must be carried out by trained personnel. At the time of screening (V1) at least 40 mm on a 100-mm visual analog scale (VAS) for average pain over the previous 24 hours. Patient-reported daily 11-point NRS (for average pain over the last 24 hours) meets the criteria specified in "Appendix B: Blinded Information" during both the 7-day screening and 7-day baseline periods. The algorithm will be assessed centrally. Exclusion Criteria: (To be used in conjunction with Platform Protocol criteria.) Participants fulfilling any of the following criteria are not eligible for the study. Females of childbearing potential will be excluded. Any of the following criteria will suffice to confirm a female's inability to bear children: Previous bilateral salpingectomy, bilateral salpingo-oophorectomy, or hysterectomy; Postmenopausal state (defined as 12 consecutive months of spontaneous amenorrhea without an alternative medical reason in a woman of at least 50 years of age); Premature ovarian failure (confirmed by a specialist), XY genotype, Turner syndrome, uterine agenesis. Body mass index of > 40 kg/m2. Diagnosis of alcohol or substance abuse or dependence (other than nicotine or caffeine) within the 2 years before the Screening visit. Moderate or severe renal impairment, known (documented) or defined as an estimated/calculated creatinine clearance/estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, according to the Chronic Kidney Disease Epidemiology Collaboration formula. Any of the following conditions related to corrected QT intervals using Fridericia's formula (QTcF): A QTcF > 500 ms prior to starting IP. A history of the following additional risk factors for torsade de pointes: heart failure, hypokalemia, history or family history of long QT syndrome. History of myocardial infarction, arrhythmia, other significant heart disease, or stroke. History of gastric surgery that might be expected to alter normal absorption of the IP (e.g., gastric bypass). Participants known to have participated in four or more studies for investigational pain drugs. Participants known to be non-responders to more than three previous neuropathic pain medications at adequate doses over at least 4 weeks or to have discontinued more than three such medications due to tolerability. Adequate doses (given as total daily doses) are defined as follows: 1,800 mg gabapentin; 300 mg pregabalin; opioid analgesics 60 mg oxycodone equivalent or 200 mg tramadol; 75 mg amitriptyline or equivalent tricyclic antidepressant; 60 mg duloxetine; 150 mg venlafaxine. Known hypersensitivity or contraindication to any excipients of the study drug formulation. Taking prohibited medications as described in Section 12, "Concomitant Therapy," and Appendix A, "Prohibited Medications." Major depressive episode within the 6 months before screening and/or a history of diagnosed recurrent major depressive disorder. Any of the following conditions related to suicidality: Any suicidal ideation with intent, with or without a plan, at screening, i.e., answering "yes" to questions 4 or 5 on the Suicidal Ideation section of the Baseline/Screening version of the Columbia-Suicide Severity Rating Scale (C-SSRS); Answering "yes" on any item of the Suicidal Behavior Section (except for the "non-suicidal self-injurious behavior") of the C-SSRS if this behavior occurred in the past 2 years; A lifetime history of suicide attempt (V1). Previous known or possible exposure to NRD135S.E1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Mendez
Phone
617-548-4627
Email
jmendez7@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Ramdas
Email
LRAMDAS@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Robinson-Papp, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phirum Nguyen
Phone
858-822-3108
Email
psnguyen@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Nathaniel Schuster, MD
Facility Name
South Lake Pain Institute
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Colon
Phone
352-394-0833
Email
jcolon@slpain.com
First Name & Middle Initial & Last Name & Degree
Julio Paez, MD
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandi Lattinville
Email
BLattinville@anest.ufl.edu
First Name & Middle Initial & Last Name & Degree
Amy Gunnett
First Name & Middle Initial & Last Name & Degree
Rene Przkora, MD
Facility Name
Northwestern Department of Neurology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirupa Jayaraj
Email
njayaraj@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Daniela Menichella, MD
Facility Name
MGH Department of Anesthesia, Critical Care, and Pain
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niayesh Mardmomen
First Name & Middle Initial & Last Name & Degree
Jianren Mao, MD/PhD
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriella Cedillo
Phone
212-241-0762
Email
gabriela.cedillo@mssm.edu
First Name & Middle Initial & Last Name & Degree
Kaitlyn Coyle
Phone
212-241-0190
Email
Kaitlyn.Coyle@mssm.edu
First Name & Middle Initial & Last Name & Degree
Bridgett Mueller, MD
Facility Name
Columbia University Medical Center/Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Cabrera
Phone
212-305-6035
Email
jec2273@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Thomas Brannagan, MD
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fajar Pasha
Email
fajar_pasha@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Rachel De Guzman
Email
rachel_deguzman@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
John Markman, MD
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhagyasri Dharmaraj
Phone
412-665-2903
Email
BHD20@pitt.edu
First Name & Middle Initial & Last Name & Degree
Caitlyn Mickles
Email
caitlin.m@pitt.edu
First Name & Middle Initial & Last Name & Degree
Ajay Wasan
Facility Name
VCU Department of Neurology
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiz Ata Ul Mustafa
Phone
804-482-1833
Email
Hafiz.AtaUlMustafa@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
A. Gordon Smith, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine Marecaux
Phone
818-263-5062
Email
marecj@uw.edu
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Huard
Email
huard@ortho.wisc.edu
First Name & Middle Initial & Last Name & Degree
Nalini Sehgal, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No The use of Global Unique Identifiers (GUIDs) allows data to be linked with a given research participant, without revealing any of the participant's identifiable information. All participants in NIH-funded research must have a GUID. This study is using the Biomedical Research Informatics Computing System (BRICS) GUID platform to assign GUIDs. This ID should be generated at the time of Informed Consent since it requires several pieces of patient information (e.g., last name at birth, first name at birth, sex at birth, day, month and year of birth, city and country of birth, etc.). The GUID will be a combination of letters and numbers to form a unique identifier, e.g. TBIAC412JJK. Sites should maintain a list to link the GUID to the participant.
Citations:
PubMed Identifier
20202753
Citation
Dworkin RH, Turk DC, Peirce-Sandner S, McDermott MP, Farrar JT, Hertz S, Katz NP, Raja SN, Rappaport BA. Placebo and treatment group responses in postherpetic neuralgia vs. painful diabetic peripheral neuropathy clinical trials in the REPORT database. Pain. 2010 Jul;150(1):12-16. doi: 10.1016/j.pain.2010.02.002. Epub 2010 Mar 3. No abstract available.
Results Reference
background
PubMed Identifier
34316322
Citation
Tarpey T, Petkova E, Ciarleglio A, Ogden RT. Extracting scalar measures from functional data with applications to placebo response. Stat Interface. 2021;14(3):255-265. doi: 10.4310/20-sii633.
Results Reference
background
PubMed Identifier
21494314
Citation
Tarpey T, Petkova E, Lu Y, Govindarajulu U. Optimal Partitioning for Linear Mixed Effects Models: Applications to Identifying Placebo Responders. J Am Stat Assoc. 2010 Jan 1;105(491):968-977. doi: 10.1198/jasa.2010.ap08713.
Results Reference
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Citation
Van Buuren, S., & Groothuis-Oudshoorn, K. (2011). Journal of Statistical Software mice: Multivariate Imputation by Chained Equations in R (Vol. 45). http://www.jstatsoft.org/
Results Reference
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EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA

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