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Thrombolytic Agent

Tenecteplase for Thrombolysis (TIMELESS Trial)

Phase 3
Waitlist Available
Research Sponsored by Genentech, 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 day 30 and day 90
Awards & highlights

TIMELESS Trial Summary

This trial will compare the effectiveness of a clot-busting drug to a placebo in people who have had a stroke. All participants will also receive the standard care for a stroke.

TIMELESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30 and day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ordinal modified Rankin scale (mRS) score
Secondary outcome measures
Incidence and severity of adverse events
Median NIHSS score
Mortality rate up to Day 30 and Day 90
+8 more

Side effects data

From 2008 Phase 3 trial • 223 Patients • NCT00396253
2%
Headache
2%
Nausea
1%
Pruritus
1%
Muscle Spasms
1%
Hypertension
1%
Hypotension
1%
Haemodynamic Instability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tenecteplase

TIMELESS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TenecteplaseExperimental Treatment1 Intervention
Patients in this arm will receive Tenecteplase (0.25 mg/kg, maximum 25 mg) administered as a single bolus injection over 5 seconds.
Group II: PlaceboPlacebo Group1 Intervention
Patients in this arm will receive placebo administered as a single bolus injection over 5 seconds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenecteplase
2020
Completed Phase 4
~4500

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,289 Total Patients Enrolled

Frequently Asked Questions

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

Could you please give me the total number of hospitals that are participating in this trial?

"Currently, there are 48 patients enrolled in this trial taking place at McLaren Flint in Flint, Uni of Alberta in Edmonton, Providence Portland Medical Center in Portland, and other locations."

Answered by AI

Are there empty slots in this clinical trial that new patients could fill?

"That is correct, the public clinical data indicates that this research is currently enrolling patients. This trial was first announced on March 2nd, 2019 and was most recently updated on October 27th, 2022. The total number of patients needed for this study is 456, which will be recruited from 48 different sites."

Answered by AI

Could you share any other notable studies that have used Tenecteplase?

"There are 426 clinical trial sites for Tenecteplase around the world, with 15 of those being active at this time. Of the active trials, 12 are in Phase 3."

Answered by AI

Has Tenecteplase been cleared by the FDA?

"There is a significant amount of data surrounding Tenecteplase's safety, as this is a Phase 3 trial. This drug received a score of 3."

Answered by AI
~75 spots leftby Mar 2025