Status:
UNKNOWN
Phase 2 Study of TXA127 in Post-ischemic Stroke Patients
Lead Sponsor:
Constant Therapeutics LLC
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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-ische...
Detailed 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-controlle...
Eligibility Criteria
Inclusion
- Age: 18-85 years
- BMI: 18.0-35.0 kg/m2
- 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.
- Patient resides in Israel between Hedera and Gedera
- Fugl-Meyer Assessment of Upper Extremity: 20-50 without reflex items
- Patient suffers from hemiparesis as assessed by the study investigator
- 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
- Patient agrees to participate in two physical therapy or occupational therapy sessions per week
- 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
- Woman of childbearing potential who is pregnant or planning to become pregnant, or not using birth control
- Aphasia or dementia limiting ability of patient to comply with instructions as assessed by the study investigator
- 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.)
- Drug or alcohol abuse within the last year
- 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
- Participation in a transcranial magnetic stimulation and/or other interventional stroke studies within 6 months of screening
- 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
- Any medical condition that, in the opinion of the investigator, would preclude patient participation in the study and/or analysis of results
- Significant disability prior to stroke that would impact execution of any of the functional assessments in the protocol
Key Trial Info
Start Date :
November 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06135103
Start Date
November 26 2023
End Date
September 1 2025
Last Update
December 21 2023
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel