Phase 2 Study of TXA127 in Post-ischemic Stroke Patients - Trial NCT06135103
Access comprehensive clinical trial information for NCT06135103 through Pure Global AI's free database. This Phase 2 trial is sponsored by Constant Therapeutics LLC and is currently Recruiting. The study focuses on Ischemic Stroke. Target enrollment is 50 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Constant Therapeutics LLC
Timeline & Enrollment
Phase 2
Nov 01, 2023
Sep 01, 2025
Primary Outcome
Fugl-Meyer Assessment of Upper Extremity (FM-UE),Adverse Events
Summary
This is a 50-patient, Phase 2, double-blind, randomized, placebo-controlled, hybrid
 decentralized study to evaluate the safety and efficacy of daily subcutaneous (SC) injection
 of TXA127 in post-ischemic stroke patients. Subjects will receive either TXA127 0.5mg/kg or
 placebo for 12 weeks started 6 to 24 months post ischemic stroke, and they will have a 12
 week follow up visit after treatment has ended. The primary efficacy outcome measure is
 individual patient absolute change from baseline in motor and sensory functions as measured
 by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) 12 weeks after start of treatment.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06135103
Non-Device Trial