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TF0023 for Ischemic 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

TF0023 Trial Summary

This trial studies the effects of a spray on stroke recovery. It's a double-blind, placebo-controlled study to see if it works.

Eligible Conditions
  • Ischemic Stroke
  • Stroke

TF0023 Trial 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

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

TF0023 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
~7 spots leftby Oct 2024
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