SYCAMORE (Recursion)

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

  1. 18 years of age or older with anatomic CCM lesions demonstrated by brain MRI
  2. Have symptomatic CCM
  3. Have provided written informed consent to participate in the study
  4. 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

NCT ID

NCT05085561