← Back to Search

Beta Blocker

Celiprolol for Ehlers-Danlos Syndrome (DiSCOVER Trial)

Phase 3
Recruiting
Research Sponsored by Acer Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able and willing to discontinue use of β-blockers 28 days prior to enrollment
A genetic test confirming the presence of a pathogenic COL3A1 variant (classified as likely pathogenic or pathogenic according to ACMG/AMP Guidelines)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over the double-blind period (estimated to be 40 months)
Awards & highlights

DiSCOVER Trial Summary

This trial will test if celiprolol is effective in treating patients with a genetic disorder that causes weak and fragile blood vessels.

Who is the study for?
This trial is for individuals with genetically confirmed vascular Ehlers-Danlos Syndrome (vEDS) who are at least 15 years old. Participants must not have had certain medical events like arterial rupture in the past 6 months, be pregnant, or use β-blockers within 28 days prior to starting the study.Check my eligibility
What is being tested?
The study tests Celiprolol's effectiveness against a placebo in patients with vEDS. It's a Phase 3 trial where participants are randomly assigned to receive either Celiprolol or a placebo twice daily, and it uses remote monitoring methods.See study design
What are the potential side effects?
While specific side effects of Celiprolol aren't listed here, common ones may include low blood pressure, dizziness, fatigue, headache, upset stomach or heart-related issues. Placebo pills typically have no active ingredients but can cause perceived side effects.

DiSCOVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can stop taking β-blockers 28 days before joining the study.
Select...
I have a confirmed genetic mutation in the COL3A1 gene.
Select...
I am 15 years old or older.

DiSCOVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over the double-blind period (estimated to be 40 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and over the double-blind period (estimated to be 40 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 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
Secondary outcome measures
Number and percentage of Serious Adverse Events (SAE)
Number and percentage of patient deaths
Number and percentage of patient discontinuations
+2 more

DiSCOVER Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo BIDExperimental Treatment1 Intervention
Placebo twice daily (BID) Placebo given orally to mimic ACER-002 (celiprolol) administration
Group II: ACER-002 (celiprolol) 200 mg BIDExperimental Treatment1 Intervention
ACER-002 200 mg twice daily (BID) (after titration): 200 mg morning and 200 mg evening: 400 mg total daily dose Titration: Day 1 to Month 1 - 100 mg once daily (QD) evening: 100 mg total daily dose Month 2 to Month 3 - 100 mg morning and 100 mg evening: 200 mg total daily dose Month 3 to Month 4 - 100 mg morning and 200 mg evening: 300 mg total daily dose Month 4 to End of Treatment Period (BID) - 200 mg morning and 200 mg evening: 400 mg total daily dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo BID
2021
Completed Phase 3
~640

Find a Location

Who is running the clinical trial?

Acer Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
73 Total Patients Enrolled

Media Library

Celiprolol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT05432466 — Phase 3
Ehlers-Danlos Syndrome Research Study Groups: ACER-002 (celiprolol) 200 mg BID, Placebo BID
Ehlers-Danlos Syndrome Clinical Trial 2023: Celiprolol Highlights & Side Effects. Trial Name: NCT05432466 — Phase 3
Celiprolol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432466 — Phase 3

Frequently Asked Questions

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

Are people still being enrolled in this research project?

"The clinicaltrials.gov website shows that this study is still looking for volunteers. The listing was first posted on November 7th, 2022 and updated the next day."

Answered by AI

If a patient is below the age of 35, can they still partake in this test?"

"Patients that meet the age requirement of 15-64 years old are eligible for this clinical trial."

Answered by AI

How many individuals are participating in this experiment?

"As shown on clinicaltrials.gov, this trial is currently recruiting patients. The first posting was on November 7th, 2022 and the last update was on November 8th, 2022. Up to 150 individuals can participate at the single site."

Answered by AI

Who meets the requirements to participate in this experiment?

"This study is for patients aged 15-64 who have ehlers-danlos syndrome and meet the following criteria: A positive genetic test for a pathogenic COL3A1 variant, discontinuation of β-blocker use 28 days before enrollment, willingness to obtain an MRA image."

Answered by AI

Has the FDA given their stamp of approval to ACER-002 (celiprolol) 200 mg BID?

"We believe that ACER-002 (celiprolol) 200 mg BID is safe based on our 3-point scale. This medication has gone through Phase 3 trials, which means that not only was it shown to be effective, but multiple rounds of testing confirm its safety."

Answered by AI
~81 spots leftby Oct 2025