The Symptomatic Cerebral Cavernous Malformation Trial of REC-994

Completed · Phase 2 · Has a placebo group

Conditions studied: Cerebral Cavernous Malformation

In brief

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).

Key facts

Study ID

NCT05085561

Run by

Recursion Pharmaceuticals Inc.

People needed

62

Starts

2022-03-17

Expected to finish

2025-06-30

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 5 half-lives of the investigational drug (whichever is longer) prior to Screening

You may not qualify if…

• Symptoms deemed by the study Investigator to be caused exclusively by irreversible neuronal damage from prior stroke or neurosurgical instrumentation
• History of cranial irradiation or surgical/radiosurgical treatment of the primary symptomatic CCM lesion
• Pregnant or breast feeding
• Be unable or unwilling to participate in MRI assessments (e.g., claustrophobia, metal implant or implanted cardiac pacemaker)
• Liver dysfunction or active liver disease as defined by baseline serum transaminases >2x upper limit of normal (ULN)
• Have moderately or severely impaired renal function (estimated glomerular filtration rate [eGFR] <60ml/min) or active renal disease or have previously received a kidney transplant
• Have had a previous diagnosis of skeletal muscle disorders (myopathy) of any cause or have a baseline creatine kinase level > 5x ULN
• History of alcohol or substance abuse within 1 year prior to screening
• Clinically significant laboratory abnormality
• Have had an intracerebral hemorrhage within 3 months of screening or any brain surgery within 6 months of screening (not including the primary symptomatic CCM lesion)

Where it is running

• Xenoscience Inc — Phoenix, Arizona, United States
• UCLA — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Florida — Gainesville, Florida, United States
• Lyerly Neurosurgery — Jacksonville, Florida, United States
• 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

Full record on ClinicalTrials.gov

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