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/ / 297DP201
A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain
PLS AVAILABLE
Study Identifier297DP201
Clinicaltrials.gov
#NCT05895552
Other
#901-C-2102
Details
Development Status
Discontinued
Study Type
Interventional
Results Available
Yes
Study Dates
07/2023 - 11/2024
Enrollment
209
Study Drug
RTA 901, RTA 901-Matching Placebo
Summary
This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of RTA 901 in qualified participants with Diabetic Peripheral Neuropathic Pain (DPNP). Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and RTA 901-maching placebo. The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1. The duration of each part of the study will be approximately 20 weeks, including a Screening period of up to 2 weeks, a Run-in-period of 2 weeks, a Treatment period of 12 weeks, and a Follow-up period of 4 weeks. All participants in Part 1 and Part 2 of the study will follow the same visit and assessment schedule. Eligibility will be assessed during the Screening and Run-in-periods.
Study Results
View and download the Results Summaries with the results of this completed study.
PDF
CSR Synopsis
PDF Document
PDF
Plain Language Summary
PDF Document
View study results on registries