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RTA 901 · CYPRESS

A Study of RTA 901 (BIIB143) in Participants With Diabetic Peripheral Neuropathic Pain

Ensayo de BIOGEN INC. en Diabetic Peripheral Neuropathic Pain (del registro, en inglés).

Fase

Fase 2

Estado

Interrumpido

Participantes

209

previstos

Centros

75

Fin del objetivo primario

nov 2024

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jul 2023.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision to close study early; not due to safety concerns.».

Qué mide

Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12 (del registro, en inglés) (inicio y semana 12)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05895552), actualizada en nov 2025.