Enzastaurin 500 mg QD for Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Aytu BioPharma, Englewood, CO
Syndrome+2 More
Enzastaurin - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein.

Eligible Conditions

  • Syndrome
  • Vascular Ehlers Danlos Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 30 months

30 months
Number of and proportion of patients who discontinue study drug due to adverse events
Number of and proportion of patients with adverse events, or with abnormal vital signs, physical examinations, ophthalmological examinations, clinical laboratory values, or electrocardiograms (ECGs) medical attention.
Time to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Enzastaurin 500 mg QD
1 of 2
Placebo QD
1 of 2
Active Control
Non-Treatment Group

260 Total Participants · 2 Treatment Groups

Primary Treatment: Enzastaurin 500 mg QD · Has Placebo Group · Phase 3

Placebo QD
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Enzastaurin 500 mg QD
Drug
ActiveComparator Group · 1 Intervention: Enzastaurin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 months
Closest Location: Aytu BioPharma · Englewood, CO
Photo of colorado 1Photo of colorado 2Photo of colorado 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Syndrome
0 CompletedClinical Trials

Who is running the clinical trial?

Aytu BioPharma, Inc.Lead Sponsor
5 Previous Clinical Trials
63 Total Patients Enrolled
1 Trials studying Syndrome
40 Patients Enrolled for Syndrome
ParexelIndustry Sponsor
265 Previous Clinical Trials
94,694 Total Patients Enrolled
1 Trials studying Syndrome
7 Patients Enrolled for Syndrome
Shaine Morris, M.D.,M.P.H.Principal InvestigatorTexas Children's Hospital and Baylor College of Medicine
Sherene Shalhub, M.D., M.P.H.Principal InvestigatorUniversity of Washington

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a confirmed and documented COL3A1 genetic variant.
You are using contraception.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.