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Brief Title: The Symptomatic Cerebral Cavernous Malformation Trial of REC-994
Official Title: A Two-Part Study of REC-994 in the Treatment of Adults With Symptomatic Cerebral Cavernous Malformation (CCM); Part 1: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Two Doses of REC-994; Part 2: A Long-Term Blinded Extension Clinical Trial to Evaluate Long-Term Safety Tolerability and Efficacy of REC-994
Study ID: NCT05085561
Brief Summary: This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to investigate the safety, efficacy and pharmacokinetics of REC-994 (200 mg and 400 mg) compared to placebo in subjects with symptomatic cerebral cavernous malformation (CCM).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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Cleveland Clinic Florida, Port Saint Lucie, Florida, United States
Emory, Atlanta, Georgia, United States
Valley Hospital, Ridgewood, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Virginia, Charlottesville, Virginia, United States