Open Actively Recruiting

The Symptomatic Cerebral Cavernous Malformation Trial of REC-994

About

Brief Summary

This is a 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
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 6 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 (eg, 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 severely impaired renal function (eGFR <60ml/min) or active renal disease
  • 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

Join this Trial

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Study Stats
Protocol No.
21-001231
Category
Neurosurgery
Contact
Melissa Arevalo
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05085561
For detailed technical eligibility, visit ClinicalTrials.gov.