The Symptomatic Cerebral Cavernous Malformation Trial of REC-994 (NCT05085561) | Clinical Trial Compass
CompletedPhase 2
The Symptomatic Cerebral Cavernous Malformation Trial of REC-994
United States62 participantsStarted 2022-03-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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