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Monoclonal Antibodies

Dose 2 TS23 for Ischemic Stroke (SISTER Trial)

Phase 2

Recruiting

Research Sponsored by Translational Sciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Suspected anterior circulation acute ischemic stroke

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration.

Awards & highlights

SISTER Trial Summary

This trial is testing a new drug called TS23 in patients who have had a stroke. It is a Phase-II trial, which means it is still in the early stages of testing. The trial will

Who is the study for?

This trial is for adults 18+ who've had a stroke affecting the brain's anterior circulation, with specific imaging results showing a moderate to severe impact. They must be able to start treatment within 4.5 to 24 hours after the stroke or when they were last known well.Check my eligibility

What is being tested?

The SISTER trial is testing TS23, an antibody targeting a clotting factor in blood, as a new treatment for acute ischemic strokes. Participants are randomly chosen to receive either TS23 or a placebo without knowing which one they get.See study design

What are the potential side effects?

While not specified here, monoclonal antibodies like TS23 can cause allergic reactions, infusion-related discomforts, and may affect bleeding or clotting mechanisms due to their action on blood proteins.

SISTER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am suspected to have a stroke affecting the front part of my brain.

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My brain scans show a specific level of stroke damage that meets the trial's criteria.

SISTER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 (±1) h, and 30 (±4) h, 30 (±5) days, and 90 (±7) days, after completion of study drug administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS)

The proportion of patients with ANY intracerebral hemorrhage (ICH)

Secondary outcome measures

% brain tissue reperfusion

Evaluation of anti-drug antibodies

Frequency of excellent functional outcome

+10 more

SISTER Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 4 TS23Experimental Treatment1 Intervention

highest dose

Group II: Dose 3 TS23Experimental Treatment1 Intervention

next higher dose

Group III: Dose 2 TS23Experimental Treatment1 Intervention

next higher dose

Group IV: Dose 1 TS23Experimental Treatment1 Intervention

low dose

Group V: PlaceboPlacebo Group1 Intervention

Placebo

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaOTHER

933 Previous Clinical Trials

7,394,336 Total Patients Enrolled

15 Trials studying Ischemic Stroke

20,475 Patients Enrolled for Ischemic Stroke

National Institutes for Neurologic Disorders and Stroke (NINDS)UNKNOWN

Translational Sciences, Inc.Lead Sponsor

2 Previous Clinical Trials

56 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process still open for individuals interested in participating in this trial?

"According to clinicaltrials.gov, the current trial is not actively seeking participants. Although it was initially listed on 3/1/2024 and last revised on 2/20/2024, no candidates are being sought presently. Nonetheless, there are currently 1184 other trials open for enrollment."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"At present, this medical research endeavor is accepting participants at 9 different locations. These include San Diego, New Haven, and Atlanta among others. Opting for the site nearest to you is advisable to reduce travel requirements should you decide to join."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"As per the trial sponsor, Translational Sciences, Inc., the primary endpoint will be determined approximately 30 hours after administration of the investigational drug and focuses on identifying patients with any intracerebral hemorrhage (ICH). Secondary endpoints include assessing anti-drug antibody levels to characterize therapeutic antibodies, determining the frequency of excellent functional outcomes based on a modified Rankin scale score of 0-1 indicating symptom-free status, and evaluating stroke severity using NIHSS scores ranging from 0 to 42. An adjustment for baseline NIHSS values will be incorporated into data analysis."

Answered by AI

What is the safety profile of Dose 2 TS23 in patients?

"In this Phase 2 trial, Dose 2 TS23 has been assessed with a safety rating of 2 due to the presence of limited safety data and no evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Strategy for Improving Stroke Treatment Response

2024. "Strategy for Improving Stroke Treatment Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948566.