Phase 2 Study of TXA127 in Post-ischemic Stroke Patients

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a safety, tolerability, and efficacy study in patients with sensorimotor deficits after confirmed middle cerebral artery ischemic stroke. The study will be double-blinded and placebo-controlled and conducted over a period of approximately 6 months, with treatment starting 6-24 months after stroke. After obtaining informed consent, eligibility will be determined by review of medical history and assessments of patient's condition. To establish a baseline, all assessments will be completed prior to administration of the first dose of study drug. Patients will be randomized (1:1) to receive either subcutaneous (SC) placebo or TXA127 (0.5 mg/kg) injections once daily for 12 weeks. In addition to receiving either the study drug or placebo, patients will be required to undergo physical therapy (PT) or occupational therapy (OT) at least twice a week. Patients will be followed up for 12 weeks after end of treatment. Throughout the study, study visits will be conducted at the medical center and the patient's home. At certain planned study visits, patients will undergo a brief physical examination, and blood will be drawn for safety evaluation and for measuring biomarkers. At the Screening, Week 12, and Week 24 visits, patients will rate their disability and health-related quality of life using the Stroke Impact Scale. In addition, upper and lower extremity motor and sensory function (FMA-UE/LE), and gait velocity (Timed Up and Go) will be evaluated. Patients will be asked to report of any safety events throughout the study and follow up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06135103
Study type	Interventional
Source	Constant Therapeutics LLC
Contact	Richard L Franklin, MD, PhD
Phone	1-617-245-0289
Email	rfranklin@constanttherapeutics.com
Status	Recruiting
Phase	Phase 2
Start date	November 26, 2023
Completion date	September 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05196659` - Collaborative Quality Improvement (C-QIP) Study	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Completed	`NCT03281590` - Stroke and Cerebrovascular Diseases Registry
Recruiting	`NCT05518305` - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT03728738` - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke	Phase 3
Terminated	`NCT03396419` - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting	`NCT05065216` - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)	Phase 2/Phase 3
Recruiting	`NCT04897334` - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke	N/A
Not yet recruiting	`NCT06462599` - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting	`NCT06032819` - Differentiating Between Brain Hemorrhage and Contrast
Not yet recruiting	`NCT06026696` - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Recruiting	`NCT02910180` - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed	`NCT02922452` - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects	Phase 1
Completed	`NCT03554642` - Walkbot Robotic Training for Improvement in Gait	Phase 3
Withdrawn	`NCT01866189` - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke	N/A
Recruiting	`NCT03041753` - Reperfusion Injury After Stroke Study	N/A
Completed	`NCT02549846` - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial	Phase 4
Completed	`NCT02610803` - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke	N/A
Completed	`NCT01678534` - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.