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Celiprolol for Ehlers-Danlos Syndrome (DiSCOVER Trial)
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.
DiSCOVER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDiSCOVER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DiSCOVER Trial Design
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Who is running the clinical trial?
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- I can stop taking β-blockers 28 days before joining the study.I am not taking any medications that are not allowed in the study.I have not had any major artery, uterus, or intestine ruptures in the last 6 months.I cannot stop taking β-blocker medication for 28 days before joining.I am unable or unwilling to follow the study's required procedures.I have a confirmed genetic mutation in the COL3A1 gene.I am 15 years old or older.My test for COL3A1 was either negative or showed a variant not linked to disease.
- Group 1: ACER-002 (celiprolol) 200 mg BID
- Group 2: Placebo BID
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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