Open
Actively Recruiting
The Symptomatic Cerebral Cavernous Malformation Trial of REC-994
About
Brief 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 subjects with symptomatic cerebral cavernous malformation (CCM).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
- 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)
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
21-001231
Category
Brain/Neurological Diseases
Principal Investigator
Contact
Location
- UCLA Westwood