The Symptomatic Cerebral Cavernous Malformation Trial of REC-994 (SYCAMORE)

If you are an adult and have a disease called cerebral cavernous malformation (CCM) you may be eligible to participate in a study to investigate the safety and efficacy of an investigational drug called REC-994 in patients with symptomatic CCM. About 60 adults will take part in this study.

The study will test REC-994, a new drug that is being developed for treating people with CCM.

The goal of this study is to see how well people with CCM tolerate treatment with REC-994 and to assess the overall safety of REC-994.The study will also assess how someone's body processes REC-994 (known as “pharmacokinetics”).

In this study, treatment with REC-994 will be compared with placebo (a substance that looks like an active drug, but has no drug or other active ingredients). If you participate in this study, you will have a 2 in 3 (66%) chance of receiving active study drug and a 1 in 3 (33%) chance of receiving placebo.

Participation in the study can last up to 15 months.  During the study, people who participate will have to come for an in-person appointment a number of times, as well as have MRI images taken of their brain, fill out a number of surveys about their symptoms, and complete a daily diary about their symptoms through an electronic app.

If you are interested in participating, please click here to find the site closest to you.

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University of Florida

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Hans Shuhaiber, MD

hshuhaiber@ufl.edu

Cleveland Clinic Florida

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Valley Hospital

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Columbia University Medical Center

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University of Rochester Medical Center

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Thomas Jefferson University

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University of Pennsylvania

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University of Pittsburgh

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The University of Texas Southwestern Medical Center

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