The Symptomatic Cerebral Cavernous Malformation Trial of REC-994
NCT ID: NCT05085561
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2022-03-17
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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REC-994 200 mg
REC-994 200 mg po once daily (QD) (1 200 mg REC-994 tablet, 1 matching placebo tablet)
REC-994
REC-994 200 mg tablets
Placebo
Placebo Tablets
REC-994 400 mg
REC-994 400 mg po QD (2 200 mg REC-994 tablets)
REC-994
REC-994 200 mg tablets
Placebo
Matching Placebo po QD (2 matching placebo tablets)
Placebo
Placebo Tablets
Interventions
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REC-994
REC-994 200 mg tablets
Placebo
Placebo Tablets
Eligibility Criteria
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Inclusion Criteria
2. Have symptomatic CCM
3. Have provided written informed consent to participate in the study
4. 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
2. History of cranial irradiation or surgical/radiosurgical treatment of the primary symptomatic CCM lesion
3. Pregnant or breast feeding
4. Be unable or unwilling to participate in MRI assessments (e.g., claustrophobia, metal implant or implanted cardiac pacemaker)
5. Liver dysfunction or active liver disease as defined by baseline serum transaminases \>2x upper limit of normal (ULN)
6. 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
7. Have had a previous diagnosis of skeletal muscle disorders (myopathy) of any cause or have a baseline creatine kinase level \> 5x ULN
8. History of alcohol or substance abuse within 1 year prior to screening
9. Clinically significant laboratory abnormality
10. 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)
18 Years
ALL
No
Sponsors
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Recursion Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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REC-994-201
Identifier Type: -
Identifier Source: org_study_id
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