VEDS Clinical Trial - Celiprolol

A new way to do clinical trials. AT HOME



DECENTRALIZED STUDY for Vascular Ehlers-Danlos Syndrome Treatment

Decentralized Study of Celiprolol on vEDS-related Event Reduction

Zevra Therapeutics plans to conduct a clinical trial in the U.S. to evaluate the efficacy of a medicine known as celiprolol for the treatment of vascular Ehlers-Danlos Syndrome (vEDS).

Objective

The study is being planned to evaluate males and females who have a confirmed diagnosis of vEDS by a COL3A1 mutation verified by genetic testing.

As planning for the trial progresses, we are actively looking for potential participants with a confirmed diagnosis of vEDS who are interested in participating in this investigational trial.

As with any clinical study, participation will be subject to a number of inclusion and exclusion criteria.

About Celiprolol

Celiprolol is an investigational product and the safety and efficacy has not been established.

There is no guarantee that celiprolol will receive health authority approval or become commercially available for vEDS in the U.S.

Inclusion Criteria:

To pre-qualify for this clinical research study, you must meet the following criteria:

• Must be greater than or equal to 15 years old
• Willing to obtain a magnetic resonance angiogram (MRA) image
• During screening, must have a genetic test performed, via a saliva sample, to confirm the presence of the COL3A1 mutation which will confirm a vEDS diagnosis; you will need a positive test result
• Must be able and willing to discontinue use of beta blockers under the care of your primary physician
• Should not have had an arterial rupture or dissection, uterine rupture, and/or intestinal rupture within the last 6 months
• Must be willing to complete all study procedures

Please note this is a summary of the main criteria to assess pre-eligibility and is not an exhaustive list