ACER-002 (celiprolol) 200 mg BID for Ehlers-Danlos Syndrome
Phase-Based Progress Estimates
Effectiveness
Safety
Science 37, Culver City, CA
Ehlers-Danlos Syndrome+2 More
ACER-002 (celiprolol) 200 mg BID - DrugEligibility
< 65
All Sexes
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Eligibility
< 65
All Sexes
What conditions do you have?
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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
This is further along than 85% of similar trials
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
This is further along than 85% of similar trials
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: DrugACER-002 (celiprolol) 200 mg BID
Drug
Experimental Group · 1 Intervention: ACER-002 (celiprolol) 200 mg BID · Intervention Types: DrugTreatment
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 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.
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