EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
- Conditions
- Painful Diabetic Neuropathy
- Interventions
- Drug: NRD135SE.1Other: Placebo
- Registration Number
- NCT05480228
- Lead Sponsor
- James P. Rathmell, MD
- 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.
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 NRD135S.E1 80mg/day NRD135SE.1 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. Matching placebo Placebo A matching placebo comparator will be used.
- Primary Outcome Measures
Name Time Method To demonstrate that NRD135S.E1 80 mg daily is superior to placebo in relieving neuropathic pain associated with PDPN, after 13 weeks' treatment. 13 weeks 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. 13 weeks 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
Name Time Method Occurrence of 50% reduction of WAP from Baseline to Week 13. 13 weeks Weekly Average Pain is abbreviated as WAP.
Occurrence of 30% reduction of WAP from Baseline to Week 13. 13 weeks Weekly Average Pain is abbreviated as WAP.
Trial Locations
- Locations (26)
NYU Langone Manhattan
🇺🇸New York, New York, United States
University of California, San Diego
🇺🇸San Diego, California, United States
South Lake Pain Institute
🇺🇸Clermont, Florida, United States
SIMEDHealth LLC
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Northwestern Department of Neurology
🇺🇸Chicago, Illinois, United States
Healthcare Research Network (Flossmoor)
🇺🇸Flossmoor, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Maryland - Baltimore
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
MGH Department of Anesthesia, Critical Care, and Pain
🇺🇸Boston, Massachusetts, United States
Healthcare Research Network (Hazelwood)
🇺🇸Hazelwood, Missouri, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Columbia University Medical Center/Neurological Institute
🇺🇸New York, New York, United States
University of Rochester
🇺🇸Rochester, New York, United States
Clinical Inquest Center
🇺🇸Beavercreek, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Low Country Pain Center
🇺🇸Orangeburg, South Carolina, United States
American Indian Clinical Trials Research Network
🇺🇸Rapid City, South Dakota, United States
Nerve and Muscle Center of Texas
🇺🇸Houston, Texas, United States
Clinicore International
🇺🇸Houston, Texas, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
VCU Department of Neurology
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States