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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
TXA127, a pharmaceutically formulated angiotensin (1-7) heptapeptide, identical to the endogenously produced, non-hypertensive derivative of angiotensin II (Ang II) is a sterile solution containing angiotensin (1-7) \[A(1-7)\], supplied in a 3 mL, single-use, stoppered vial.
Placebo is a sterile solution containing supplied in a 3 mL, single-use, stoppered vial.
Sheba Medical Center
Ramat Gan, Israel
RECRUITINGFugl-Meyer Assessment of Upper Extremity (FM-UE)
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.
Time frame: 12 weeks
Adverse Events
Incidence of adverse events (AEs) assessed according to CTCAE v5.0
Time frame: 12 weeks
Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
Individual patient absolute change from baseline in motor and sensory functions as measured by the Fugl-Meyer Assessment of Lower Extremity (FMA-LE) 12 weeks after start of treatment.
Time frame: 12 weeks
Time Up and Go
Percent change from baseline gait velocity as measured by Timed Up and Go 12 weeks after start of treatment
Time frame: 12 weeks
Stroke Impact Scale
Absolute change from patient's baseline self-assessment as measured by Stroke Impact Scale 12 weeks after start of treatment, scored 0 to 100 with higher scores indicating higher quality of life
Time frame: 12 weeks
Durability of Fugl-Meyer
Absolute change in motor and sensory function as measured by the Fugl-Meyer Assessment of Upper and lower Extremity (FMA-UE \& FMA-LE)
Time frame: 24 weeks
Durability of Time Up and Go
Percent change in gait velocity as measured by Timed Up and Go
Time frame: 24 weeks
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Masking
QUADRUPLE
Enrollment
50
Durability of Stroke Impact Scale
Absolute change in patient self-assessment as measured by Stroke Impact Scale over the 12-week follow-up period (12-24 weeks after the start of treatment); scored 0 to 100 with higher scores indicating higher quality of life
Time frame: 24 weeks