Evaluating TXA127 for improving recovery 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

This study is testing if a new drug called TXA127 can help people recover better after having an ischemic stroke compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Constant Therapeutics LLC (Industry-sponsored)
• Locations: 1 site (Ramat Gan)
• Trial ID: NCT06135103 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial investigates the safety and efficacy of TXA127, administered via daily subcutaneous injections, in patients who have experienced an ischemic stroke. The study involves 50 participants who will be randomly assigned to receive either TXA127 or a placebo for 12 weeks, starting 6 to 24 months after their stroke. Participants will also engage in physical or occupational therapy sessions twice a week, and their progress will be monitored through various assessments, including the Fugl-Meyer Assessment for motor and sensory functions. The study aims to determine the impact of TXA127 on recovery outcomes compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have experienced a middle cerebral artery ischemic stroke 6-24 months prior and have hemiparesis.

Not a fit: Patients with significant premorbid disabilities affecting their physical and cognitive functions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance recovery of motor and sensory functions in patients who have suffered an ischemic stroke.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in enhancing recovery post-stroke, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-85 years
2. BMI: 18.0-35.0 kg/m2
3. Patient suffered an ischemic stroke (caused by blockage of the middle cerebral artery) 6-24 months prior to enrollment and with no additional symptomatic stroke incidents since then.
4. Patient resides in Israel between Hedera and Gedera
5. Fugl-Meyer Assessment of Upper Extremity: 20-50 without reflex items
6. Patient suffers from hemiparesis as assessed by the study investigator
7. Premorbid disability does not impact physical and cognitive function to a degree that would limit completion of study activities and assessments, as assessed by the study investigator
8. Patient agrees to participate in two physical therapy or occupational therapy sessions per week
9. Patient is able to use a device for telemedicine meetings with a physician and to record study-related events in an electronic diary, either alone or with caregiver's assistance

Exclusion Criteria:

1. Woman of childbearing potential who is pregnant or planning to become pregnant, or not using birth control
2. Aphasia or dementia limiting ability of patient to comply with instructions as assessed by the study investigator
3. Current diagnosis of severe depression (NOTE: In case of doubt, a patient who is currently taking or has taken within the last 30 days second-line anti-depressants OR who has scored 12-15 points using the Geriatric Depression Scale, will be considered severely depressed and will not be eligible to participate in the study.)
4. Drug or alcohol abuse within the last year
5. Current or planned Botox administration for upper limb spasticity, strabismus, overactive bladder, migraine prevention, blepharospasm, cervical dystonia or other off-label uses including but not limited to: sialorrhea, post-herpetic neuralgia, Raynaud's disease, achalasia, or any use the investigator believes may interfere with an accurate neurological exam. Permitted uses - cosmetic (wrinkles), hyperhidrosis
6. Participation in a transcranial magnetic stimulation and/or other interventional stroke studies within 6 months of screening
7. History of cancer within three years of screening, with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months
8. Any medical condition that, in the opinion of the investigator, would preclude patient participation in the study and/or analysis of results
9. Significant disability prior to stroke that would impact execution of any of the functional assessments in the protocol

Where this trial is running

Ramat Gan

• Sheba Medical Center — Ramat Gan, Israel (Recruiting)

Study contacts

• Study coordinator: Richard L Franklin, MD, PhD

Conditions Ischemic Stroke