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TF0023 for Stroke (TF0023 Trial)

Phase 2
Waitlist Available
Research Sponsored by Techfields Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 and 32 weeks of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing TF0023 spray to see if it helps people recover better after an ischemic stroke. The spray is used regularly, and researchers want to find out if it improves patients' ability to function independently.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 and 32 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 and 32 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary efficacy endpoint is the change from baseline in the mRS score for all randomized patients at Week 16 in Part A and Part B.
Secondary study objectives
Barthel Index (BI) changes after signing the informed consent form through Week 16 and Week 32.
Blood flow in neck arteries by Ultrasonography after signing the informed consent form through Week 16 and Week 32.
Blood pressure changes after signing the informed consent form through Week 16 and Week 32.
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Middle doseExperimental Treatment1 Intervention
75 patients will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 \[50 patients\] and placebo \[25 patients\]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 60 days after the onset of stroke symptoms (Day 1 of the study).
Group II: Low doseExperimental Treatment1 Intervention
75 patients will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 \[50 patients\] and placebo \[25 patients\]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 60 days after the onset of stroke symptoms (Day 1 of the study).
Group III: High doseExperimental Treatment1 Intervention
75 patients will be randomized to active or placebo treatment in a 2:1 ratio (TF0023 \[50 patients\] and placebo \[25 patients\]). Each patient enrolled in Group A will receive study treatment in a double-blind manner for 16 weeks starting between 3 and 60 days after the onset of stroke symptoms (Day 1 of the study).

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Who is running the clinical trial?

Techfields IncLead Sponsor
1 Previous Clinical Trials
19 Total Patients Enrolled
Chongxi Yu, Ph.DStudy ChairTechfields Inc
1 Previous Clinical Trials
19 Total Patients Enrolled
~26 spots leftby Nov 2025
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