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NTS-104 TRIS for Stroke

Phase 1
Recruiting
Research Sponsored by NeuroTrauma Sciences, LLC
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 blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
Awards & highlights

Study Summary

This trial will test the safety of NTS-104 TRIS, given as a single intravenous dose, to healthy subjects at different doses.

Eligible Conditions
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood will be drawn from each patient prior to the start of the infusion, at 30, 60, 75, 90, 105, 120, 150, and 180 minutes after the infusion as well as at 4, 6, 8, 12, 24, 36, and 48 hours after the infusion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events and Serious Adverse Events
Change from Baseline in Physical Examination
Change in Baseline Vital Signs
+2 more
Secondary outcome measures
AUC(0-t)
AUC(inf)
Cmax
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm 1Experimental Treatment1 Intervention
0.8, 4, 8, or 16 mg/mL NTS-104 solution for IV infusion
Group II: Treatment Arm 2Placebo Group1 Intervention
Single administration of placebo at the same volume and duration

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NeuroTrauma Sciences, LLCLead Sponsor
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,794 Total Patients Enrolled
1 Trials studying Stroke
522 Patients Enrolled for Stroke
Amy S Chappell, MDStudy DirectorNeuroTrauma Sciences, LLC

Frequently Asked Questions

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

Has the NTS-104 TRIS formulation been given clearance by the FDA?

"The consensus amongst our Power team is that NTS-104 TRIS safety rating should be a 1, due to the limited clinical evidence in Phase 1 trials for both efficacy and safety."

Answered by AI

Am I eligible to take part in this research endeavor?

"This clinical trial is admitting 32 participants who have suffered a cerebrovascular accident and are between the ages 18 to 65. To be considered, volunteers must consent in writing, possess good health as determined by physical and neurological examinations, present with normal blood pressure/heart rate levels (systolic 90-140mmHg; diastolic 50-90 mmHg; heart rate 45-100 beats per minute), carry out an approved form of birth control if applicable (abstinence, tubal ligation/occlusion , oral contraceptives etc.), report negative pregnancy test results for females at screening and admission."

Answered by AI

What objectives is this clinical trial seeking to fulfill?

"The primary outcome measure that Parexel, the study sponsor, has reported is a Change in QTcF Determined by Electrocardiogram over an 8-day period. As for secondary outcomes of this research project, Cmax (the Maximum plasma concentration computed using non-compartmental analysis), Elimination rate constant (λz) (Rate of elimination of IP via non-compartmental analysis based concentrations in plasma), and AUC(inf) (Area under the curve to infinity derived from non-compartmental analysis) will be observed."

Answered by AI

Does this research endeavor currently have any openings for participants?

"According to the information available on clinicaltrials.gov, this particular research endeavour is not currently open for enrolment. The trial was first featured on October 21st of 2022 and last modified on September 16th of that same year. Although it has closed its doors at present, there are 342 other studies actively recruiting participants across the United States right now."

Answered by AI

Is an age limit set on participation in this trial, and if so, up to what years of life?

"This experiment has identified 18 years old and above, as well as 65 years old and below, to be the eligible age range for potential participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults
2023. "Single Ascending Dose Safety and Tolerability of NTS-104 Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547438.
~17 spots leftby Apr 2025
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