NCT05085561

The Symptomatic Cerebral Cavernous Malformation Trial of REC-994

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Recursion Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 participants with symptomatic cerebral cavernous malformation (CCM).

Detailed description

Part 1: Participants will receive treatment over a period of 12 months. Part 2: Optional long-term extension (LTE) for participants completing Part 1 and who are eligible for extended treatment with REC-994.

Conditions

• Cerebral Cavernous Malformation

Interventions

Type	Name	Description
DRUG	REC-994	REC-994 200 mg tablets
DRUG	Placebo	Placebo Tablets

Timeline

• Start date: 2022-03-17
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2021-10-20
• Last updated: 2025-08-06

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study