Ischemic StrokePhase 2NCT06135103
Phase 2 Study of TXA127 in Post-ischemic Stroke Patients
A Phase 2 study testing talfirastide in people with Ischemic Stroke, run by Constant Therapeutics LLC at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- talfirastide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Nov 2023to Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Moshe Bondi, MD
Moshe Bondi, MD
About this study
Official title: 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 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.
Read the 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-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.
- Conditions
- Ischemic Stroke
- Being tested
- talfirastide, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talfirastideDrug
Also called TXA127
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.
PlaceboDrug
Placebo is a sterile solution containing supplied in a 3 mL, single-use, stoppered vial.
| Study group | Role | What they receive |
|---|---|---|
| talfirastide (TXA127) | Experimental | TXA127 will be given daily for 12 weeks at a dose of 0.5.mg/kg via SC injection. Receives: Drug: talfirastide |
| placebo | Placebo comparator | Placebo will be given daily for 12 weeks via SC injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-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.
Measured: 12 weeks
Adverse Events
Incidence of adverse events (AEs) assessed according to CTCAE v5.0
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 24 weeks
Durability of Time Up and Go
Percent change in gait velocity as measured by Timed Up and Go
Measured: 24 weeks
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start26 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Constant Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135103
- Sponsor's protocol ID
- TXA127-STRK-001
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06135103
- Acronym / sponsor ID
- TXA127-STRK-001
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Constant Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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-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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| talfirastide (TXA127) | Experimental | Drug: talfirastideTXA127 will be given daily for 12 weeks at a dose of 0.5.mg/kg via SC injection. |
| placebo | Placebo comparator | Drug: PlaceboPlacebo will be given daily for 12 weeks via SC injection. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| talfirastideAlso: TXA127TXA127, 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. | Drug | talfirastide (TXA127) |
| PlaceboPlacebo is a sterile solution containing supplied in a 3 mL, single-use, stoppered vial. | Drug | placebo |
Primary outcome
Fugl-Meyer Assessment of Upper Extremity (FM-UE)
Time frame: 12 weeks
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.
Adverse Events
Time frame: 12 weeks
Incidence of adverse events (AEs) assessed according to CTCAE v5.0
6 secondary outcomes
Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
Time frame: 12 weeks
Time Up and Go
Time frame: 12 weeks
Stroke Impact Scale
Time frame: 12 weeks
Durability of Fugl-Meyer
Time frame: 24 weeks
Durability of Time Up and Go
Time frame: 24 weeks
Durability of Stroke Impact Scale
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 2
The Efficacy and Safety of HRS-4029 in Acute Ischemic Stroke Patients
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing talfirastide in people with Ischemic Stroke, run by Constant Therapeutics LLC at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard L Franklin, MD, PhD (1-617-245-0289 ext. 101, rfranklin@constanttherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment of Upper Extremity (FM-UE) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.