EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Drug: ISA specific
- Registration Number
- NCT05476276
- Lead Sponsor
- James P. Rathmell, MD
- Brief Summary
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol.
- Detailed Description
This is a Platform Protocol that allows evaluation of more than one treatment in a single trial structure, to be run within EPPIC-Net. Instead of testing individual assets in a series of clinical trials, this Platform Protocol sets out the framework for testing multiple assets related to PDPN. This provides an efficient approach to evaluate multiple therapies under a single infrastructure in a timely fashion. The Platform Protocol also allows efficiencies by creating the possibility of sharing information across assets, such as data from control conditions.
This Platform Protocol is for a platform design to allow for the testing of multiple assets. Some platform trials allow direct comparisons of competing therapies for the same condition. However, for this EPPIC-Net platform trial, there will not be direct comparisons of assets to one another. Instead, assets will only be compared to a placebo. This is in service to the EPPIC-Net primary goal of accelerating the development of pain treatment because, based on feedback from asset-holders, the possibility of comparison of assets to one another or to an active drug would be a deterrent for asset-holders' participation in EPPIC-Net.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EN21-01 ISA ISA specific The EN21-01 Intervention Specific Analysis is detailed in the protocol (NCT#) Placebo Comparator ISA specific Each ISA will detail the use of the Placebo Comparator.
- Primary Outcome Measures
Name Time Method Daily 0-10 pain NRS Past 24 hours Typically, the primary efficacy endpoint for this Platform Protocol will be based on the daily 0-10 pain NRS. Participants will respond to the following every evening before going to bed:
* "Select the number that best describes your average neuropathy pain during the past 24 hours."
* "Select the number that best describes your worst neuropathy pain during the past 24 hours."
Typically, the primary efficacy endpoint for this Platform Protocol will be based on the daily 0-10 pain NRS. Participants will respond to the following every evening before going to bed:
* "Select the number that best describes your average neuropathy pain during the past 24 hours."
* "Select the number that best describes your worst neuropathy pain during the past 24 hours."
- Secondary Outcome Measures
Name Time Method Pain, Enjoyment, and General activity scale (PEG) Past 24 hours 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.
Pain Catastrophizing Scale - Short Form 6 (PCS-SF6) Past 24 hours 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.
PROMIS Physical Functioning Short-Form 6b Past 24 hours 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).
Pain Health Questionnaire (PHQ-2) Past 24 hours 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.
Generalized Anxiety Disorder - 2 item scale (GAD-2) Past 24 hours 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.
Patient Global Impression of Change (PGIC) Past 24 hours 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).
Tobacco, Alcohol, Prescription medication, and other Substance use Tool (TAPS-1) Past 24 hours 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.
PROMIS Sleep Disturbance - 6A Past 24 hours 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).
Sleep Duration Past 24 hours 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.
Opioid Use Questionnaire (OUQ) Past 24 hours 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
Trial Locations
- Locations (23)
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Northwestern Department of Neurology
🇺🇸Chicago, Illinois, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
University of Rochester
🇺🇸Rochester, New York, United States
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
Low Country Pain Center
🇺🇸Orangeburg, South Carolina, United States
Columbia University Medical Center/Neurological Institute
🇺🇸New York, New York, United States
Clinical Inquest Center
🇺🇸Beavercreek, Ohio, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Healthcare Research Network (Hazelwood)
🇺🇸Hazelwood, Missouri, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Healthcare Research Network (Flossmoor)
🇺🇸Flossmoor, Illinois, United States
University of Maryland - Baltimore
🇺🇸Baltimore, Maryland, United States
MGH Department of Anesthesia, Critical Care, and Pain
🇺🇸Boston, Massachusetts, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
University of Washington
🇺🇸Seattle, Washington, United States
Nerve and Muscle Center of Texas
🇺🇸Houston, Texas, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
SIMEDHealth LLC
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
VCU Department of Neurology
🇺🇸Richmond, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States