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Protein Kinase Inhibitor

Enzastaurin 500 mg QD for Ehlers-Danlos Syndrome (PREVEnt Trial)

Phase 3
Waitlist Available
Led By Sherene Shalhub, M.D., M.P.H.
Research Sponsored by Aytu BioPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights

PREVEnt Trial Summary

This trial is studying whether enzastaurin is better than placebo at preventing arterial events in patients with a certain gene mutation.

Eligible Conditions
  • Ehlers-Danlos Syndrome

PREVEnt Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
Number of and proportion of patients who discontinue study drug due to adverse events
Electrocardiogram

PREVEnt Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Enzastaurin 500 mg QDActive Control1 Intervention
Receive 500 mg enzastaurin QD plus background standard of care.
Group II: Placebo QDPlacebo Group1 Intervention
Matching placebo QD plus background standard of care.

Find a Location

Who is running the clinical trial?

Aytu BioPharma, Inc.Lead Sponsor
5 Previous Clinical Trials
23 Total Patients Enrolled
ParexelIndustry Sponsor
304 Previous Clinical Trials
100,892 Total Patients Enrolled
Sherene Shalhub, M.D., M.P.H.Principal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical InvestigationJournal
Targetable Cellular Signaling Events Mediate Vascular Pathology in Vascular Ehlers-danlos Syndrome
Bowen, Caitlin J., Juan Francisco Calderón Giadrosic, Zachary Burger, Graham Rykiel, Elaine C. Davis, Mark R. Helmers, Kelly Benke, Elena Gallo MacFarlane, and Harry C. Dietz. 2019. “Targetable Cellular Signaling Events Mediate Vascular Pathology in Vascular Ehlers-danlos Syndrome”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci130730.
clinicaltrials.govStudy
Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome.
2025. "Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05463679.
~173 spots leftby Jun 2025
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