{"id":5253,"date":"2023-01-04T08:41:33","date_gmt":"2023-01-04T16:41:33","guid":{"rendered":"https:\/\/www.iths.org\/participate\/?p=5253"},"modified":"2023-03-01T12:33:07","modified_gmt":"2023-03-01T20:33:07","slug":"painful-diabetic-peripheral-neuropathy-pdpn-study","status":"publish","type":"post","link":"https:\/\/www.iths.org\/participate\/painful-diabetic-peripheral-neuropathy-pdpn-study\/","title":{"rendered":"Painful Diabetic Peripheral Neuropathy (PDPN) Study"},"content":{"rendered":"
<\/div>\n

The EN 21-01 study is testing a new investigational medication, called NRD135S.E1, to see if it is helpful and safe for patients with painful diabetic peripheral neuropathy. NRD135S.E1 showed a decrease in pain after 3 weeks of study treatment when compared to a placebo in a small study of 88 participants. This new study will look at one dose of NRD135S.E1, 80 mg per day. This study will compare the study drug to a placebo, a pill with no active drug. NRD135S.E1 is not yet approved by the FDA.<\/p>\n

Study participation lasts approximately 6 months and includes at least 10 visits to the University of Washington Medical Center. You will be compensated $85 for each study visit and surveys completed, and the site will cover the cost of parking.<\/p>\n

If interested, please call the UW DPN Study Team<\/strong> at 206-616-9981 or the study coordinator, Justine Marecaux, at 206-221-1538, or email dpnstudy@uw.edu<\/a>.<\/strong> Dr. Maxwell Ma is the Site Principal Investigator for this research study at the University of Washington.<\/p>\n

Participant Eligibility<\/h3>\n

18 years or older<\/p>\n

Painful Diabetic Peripheral Neuropathy<\/p>\n

Willing to come to UWMC every few weeks for 6 months to participate in the study visits<\/p>\n

Contact<\/h3>\n

UW DPN Study Team
\n(206) 616-9981<\/p>\n

<\/p>\n

Additional Study Details<\/h3>\n

Full Study Title<\/strong>
\nA 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 (SERENDIPITY-1)
\n<\/span><\/p>\n

Study ID:<\/strong> Pro00063849<\/div>\n
ClinicalTrials.gov Link:<\/strong> NCT05480228<\/a><\/div>\n
<\/div>\n
Start Date:<\/strong> 09\/21\/2022<\/div>\n
End Date:<\/strong> 12\/01\/2023<\/div>\n
<\/div>\n

Investigator(s)<\/strong>
\nMaxwell Ma, MD
\n<\/span>
\nAccepts Healthy Volunteers?<\/strong>
\nNo<\/span><\/p>\n

Study Site(s)<\/strong><\/p>\n

\n

UWMC- Montlake<\/h4>\n

1959 NE Pacific St
\nSeattle, Washington 98195<\/p>\n<\/div>\n

\n

<\/h4>\n<\/div>\n
<\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

The EN 21-01 study is testing a new investigational medication, called NRD135S.E1, to see if it is helpful and safe for patients with painful diabetic peripheral neuropathy. NRD135S.E1 showed a decrease in pain after 3 weeks of study treatment when compared to a placebo in…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,5,9,19],"tags":[595,170,1395,110,1397,1234,1396],"class_list":["post-5253","post","type-post","status-publish","format-standard","hentry","category-bone-joints-muscles","category-brain-and-nervous-system","category-diabetes","category-pain-managementanesthesiology","tag-chronic-pain","tag-diabetes","tag-diabetic-peripheral-neuropathy","tag-medication","tag-neuropathic-pain","tag-pain-management","tag-painful-diabetic-peripheral-neuropathy"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5253","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/comments?post=5253"}],"version-history":[{"count":4,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5253\/revisions"}],"predecessor-version":[{"id":5342,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/posts\/5253\/revisions\/5342"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/media?parent=5253"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/categories?post=5253"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.iths.org\/participate\/wp-json\/wp\/v2\/tags?post=5253"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}