A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Diabetic Peripheral Neuropathic Pain
In brief
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.
Key facts
- Study ID
- NCT05895552
- Run by
- Reata, a wholly owned subsidiary of Biogen
- People needed
- 209
- Starts
- 2023-07-28
- Expected to finish
- 2024-11-15
- Last updated by the study team
- 2025-12-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Research Center — Phoenix, Arizona, United States
- Hope Clinical Research, Inc. — Canoga Park, California, United States
- Valley Research - Trials — Fresno, California, United States
- Clinical Research Institute — Los Angeles, California, United States
- Acclaim Clinical Research — San Diego, California, United States
- Optimus Medical Group — San Francisco, California, United States
- PIH Health Whittier Hospital — Whittier, California, United States
- Denver Endocrinology Diabetes and Thyroid Center PC — Englewood, Colorado, United States
- Paradigm Clinical Research — Wheat Ridge, Colorado, United States
- Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
- Clinical Research of West Florida Inc — Clearwater, Florida, United States
- East Coast Institute for Research, LLC — Jacksonville, Florida, United States
- Multi Specialty Research Associates, LLC — Lake City, Florida, United States
- 3 Sync LLC — Lake Worth, Florida, United States
- Finlay Medical Research — Miami, Florida, United States
- New Horizon Research Center — Miami, Florida, United States
- Floridian Clinical Research — Miami Lakes, Florida, United States
- IMA Clinical Research, PC — St. Petersburg, Florida, United States
- 3 Sync LLC — Sunrise, Florida, United States
- Genesis Clinical Research — Tampa, Florida, United States
- Clinical Research of West Florida, Inc. — Tampa, Florida, United States
- Baycare Clinical Research — Tampa, Florida, United States
- VICIS Clinical Research — Tampa, Florida, United States
- Clinical Site Partners, Orlando — Winter Park, Florida, United States
- Centricity Research Phoenix Multispecialty — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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