ACER-002 (celiprolol) 200 mg BID for Ehlers-Danlos Syndrome

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Science 37, Culver City, CA
Ehlers-Danlos Syndrome+2 More
ACER-002 (celiprolol) 200 mg BID - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a prospective, Phase 3, randomized, double-blind, placebo-controlled efficacy study to evaluate celiprolol in patients genetically confirmed as COL3A1-positive vEDS using a decentralized clinical trial design.

Eligible Conditions

  • Ehlers-Danlos Syndrome
  • Vascular Ehlers Danlos Syndrome

Treatment Effectiveness

Effectiveness Progress

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

Other trials for Ehlers-Danlos Syndrome

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Over the double-blind period (estimated to be 40 months)

Month 40
Number and percentage of Serious Adverse Events (SAE)
Number and percentage of patient deaths
Number and percentage of patient discontinuations
Number and percentage of patients with adverse events
Number and proportion of patients reporting a vEDS related clinical event requiring medical attention: Fatal/nonfatal cardiac or arterial events [including dissection or rupture], uterine rupture, intestinal rupture, and/or unexplained sudden death
Time to first occurrence of a vEDS-related clinical event requiring medical attention: Fatal/nonfatal cardiac or arterial events [including dissection or rupture], uterine rupture, intestinal rupture, and/or unexplained sudden death

Trial Safety

Safety Progress

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

Other trials for Ehlers-Danlos Syndrome

Trial Design

2 Treatment Groups

Placebo BID
1 of 2
ACER-002 (celiprolol) 200 mg BID
1 of 2
Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: ACER-002 (celiprolol) 200 mg BID · Has Placebo Group · Phase 3

Placebo BID
Drug
Experimental Group · 1 Intervention: Placebo BID · Intervention Types: Drug
ACER-002 (celiprolol) 200 mg BID
Drug
Experimental Group · 1 Intervention: ACER-002 (celiprolol) 200 mg BID · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo BID
2013
Completed Phase 3
~240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over the double-blind period (estimated to be 40 months)
Closest Location: Science 37 · Culver City, CA
2018First Recorded Clinical Trial
1 TrialsResearching Ehlers-Danlos Syndrome
2 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to have an MRA image at your local imaging facility.

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.