Phase 2 Study of TXA127 in Post-ischemic Stroke Patients

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Constant Therapeutics LLC
• Treatments: Angiotensin I (1-7)

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