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NCT06135103Recruiting

Phase 2 Study of TXA127 in Post-ischemic Stroke Patients

A 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
Constant Therapeutics LLCPhase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Ischemic Stroke
Drug/Device/Intervention
talfirastide
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Constant Therapeutics LLC
Location
Ramat Gan, Israel
Timeline & enrollment
Phase
Phase 2
Start date
Nov 01, 2023
End date
Sep 01, 2025
Enrollment
50 participants
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
Stroke, not specified as haemorrhage or infarctionSequelae of stroke, not specified as haemorrhage or infarctionCerebral infarctionCerebral infarction, unspecifiedOther cerebral infarction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06135103
Type
Non-Device Trial
About this record

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.