Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
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.
Quick Facts
Study Start:2022-09-21
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
University of California, San Diego
San Diego, California, 92037
United States
South Lake Pain Institute
Clermont, Florida, 34711
United States
SIMEDHealth LLC
Gainesville, Florida, 32607
United States
University of Florida
Gainesville, Florida, 32611
United States
Northwestern Department of Neurology
Chicago, Illinois, 60611
United States
Healthcare Research Network (Flossmoor)
Flossmoor, Illinois, 60422
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
University of Maryland - Baltimore
Baltimore, Maryland, 21201
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
United States
MGH Department of Anesthesia, Critical Care, and Pain
Boston, Massachusetts, 02114
United States
Healthcare Research Network (Hazelwood)
Hazelwood, Missouri, 63042
United States
Mount Sinai School of Medicine
New York, New York, 10029
United States
Columbia University Medical Center/Neurological Institute
New York, New York, 10032
United States
University of Rochester
Rochester, New York, 14627
United States
Clinical Inquest Center
Beavercreek, Ohio, 45431
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
United States
Low Country Pain Center
Orangeburg, South Carolina, 29118
United States
American Indian Clinical Trials Research Network
Rapid City, South Dakota, 57701
United States
Nerve and Muscle Center of Texas
Houston, Texas, 77030
United States
Clinicore International
Houston, Texas, 77077
United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Eastern Virginia Medical School
Norfolk, Virginia, 23510
United States
VCU Department of Neurology
Richmond, Virginia, 23298
United States
University of Washington
Seattle, Washington, 98195
United States
University of Wisconsin
Madison, Wisconsin, 53706
United States
Collaborators and Investigators
Sponsor: James P. Rathmell, MD
- Jessica Robinson-Papp, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2022-09-21
Study Completion Date2025-01-31
Study Record Updates
Study Start Date2022-09-21
Study Completion Date2025-01-31
Terms related to this study
Additional Relevant MeSH Terms
- Painful Diabetic Neuropathy