A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of REC-994 in the Treatment of Symptomatic Cerebral Cavernous Malformation
Objective
The purpose of this study is to investigate the safety, efficacy, and pharmacokinetics of daily doses of REC-994 (200 mg and 400 mg) compared to placebo in participants with symptomatic CCM over a treatment period of 12 months.
Study Arms
- Active Comparator: REC-994 200 mg
- Active Comparator: REC-994 400 mg
- Placebo Comparator: Placebo
Eligibility
- 18 years of age or older with anatomic CCM lesions demonstrated by brain MRI
- Have symptomatic CCM
- Have provided written informed consent to participate in the study
- Have NOT participated in a clinical trial utilizing an investigational agent within 28 days or within 6 half-lives of the investigational drug (whichever is longer) prior to Screening
